Society for Clinical Trials

SCT Annual Meeting Presentations & Videos
* Note that only Keynote Lectures and Trial of the Year are available to non-members for 2022 and 2023.
Members can login to view all presentations from recent years.

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3190 Learning Opportunities Found

Primary Presenter

Presentation Information

Media Type(s)

Merit Cudkowicz
2024 (Boston) Annual Meeting

Curtis Meinert Lecture
Advances in Neurotherapeutics Updates on ALS and NeuroNEXT

Penney Cowan
2024 (Boston) Annual Meeting

Founders Lecture
Perspective of Those With Lived Experience: Involving a Patient in Clinical Trials

Adam Devall
2024 (Boston) Annual Meeting

Trial of the Year Award
Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage

Alan T. Tita
2023 (Baltimore) Annual Meeting

Trial of the Year Award
The Chronic Hypertension and Pregnancy Treatment Trial (CHAP)

Kirsten Bibbins-Domingo
2023 (Baltimore) Annual Meeting

Founders Lecture
Medical Publishing in Dynamic Times: A View from JAMA and the JAMA Network

John P.A. Ioannidis
2023 (Baltimore) Annual Meeting

Curtis Meinert Lecture
Meta-epidemiology of evidence from clinical trials

Dong-Yun Kim
2022 (San Diego) Annual Meeting

Session Proposal
All for One, One for All: How to Run Multiple Networks of COVID-19 Clinical Trials on a Common Platform Using Bayesian Method

Session Details

Susan Ellenberg
2022 (San Diego) Annual Meeting

Session Proposal
Clinical Trials of COVID-19 Vaccines: Overcoming the Challenges

Session Details

Min Zhan
2022 (San Diego) Annual Meeting

Contributed Session
Analysis of Adverse Event and Serious Adverse Event Data from Randomized Controlled Trials

Session Details

Riaz Qureshi
2022 (San Diego) Annual Meeting

Contributed Session
Data Visualization Approaches to Presenting Harms in Clinical Trials

Session Details

Marie Kay
2022 (San Diego) Annual Meeting

Contributed Session
Assessment of a Risk-Based Quality Management Approach to Protocol Deviations - A Data Coordinating Center's Experience

Session Details

Eric Fischer
2022 (San Diego) Annual Meeting

Contributed Session
Dynamically Generating Study Monitoring Reports via Email

Session Details

J Athene Lane
2022 (San Diego) Annual Meeting

Contributed Session
Virtual Clinical Outcome Ascertainment in a Prostate Cancer Treatment Trial

Session Details

Kelly Karavolos
2022 (San Diego) Annual Meeting

Contributed Session
Challenges of Data Collection for a Fully Remote Clinical Trial with a Multi-Component Outcome: Virtual ELM Pilot Study

Session Details

Rebecca Metcalfe
2022 (San Diego) Annual Meeting

Contributed Session
Integrating Patient Values into Clinical Trials Using a Patient-Centered Composite Endpoint: A Case Study Using the Control of Hypertension in Pregnancy Study (CHIPS) Trial

Session Details

BeiBei Guo
2022 (San Diego) Annual Meeting

Contributed Session
A Biomarker-Based Dose-Finding Design for Immunotherapy

Session Details

Yunshan Duan
2022 (San Diego) Annual Meeting

Contributed Session
A Unified Decision Framework for Phase I Dose-Finding Designs

Session Details

Hakim-Moulay Dehbi
2022 (San Diego) Annual Meeting

Contributed Session
Early Phase Dose-Finding Trials in Virology

Session Details

Evan Bagley
2022 (San Diego) Annual Meeting

Contributed Session
Dose-Finding Based on Feasibility and Late-Onset Toxicity in Adoptive Cell Therapy Trials

Session Details

Jack Wolf
2022 (San Diego) Annual Meeting

Contributed Session
A Permutation Procedure to Detect Heterogeneous Treatments Effects in Randomized Clinical Trials While Controlling the Type-I Error Rate

Session Details

Peter Godolphin
2022 (San Diego) Annual Meeting

Contributed Session
Estimating Interactions and Subgroup-Specific Treatment Effects in Meta-Analysis Without Aggregation Bias: A Within-Trial Framework

Session Details

Jiyang Wen
2022 (San Diego) Annual Meeting

Contributed Session
Simultaneous Hypothesis Testing for Multiple Competing Risks in Comparative Clinical Trials

Session Details

Andrea Viecelli
2022 (San Diego) Annual Meeting

Contributed Session
Enhancing Patient-Partnership in Clinical Trials

Session Details

Mithat Gönen
2022 (San Diego) Annual Meeting

Special Presentation
Annual Business Meeting 2022

Chalmers & Green Award Presentations
2022 (San Diego) Annual Meeting

Award Presentation
Andrea Viecelli, Jiyang Wen, Peter Godolphin, Jack Wolf

Class of 2022 Fellows
2022 (San Diego) Annual Meeting

Fellows Presentation
Thomas Cook & Alexia Iasonos

Drs. Edward Mills & Gilmar Reis
2022 (San Diego) Annual Meeting

Trial of the Year Award
The TOGETHER Trial: An Adaptive Platform International Trial

Dr. Robert Califf, FDA Commissioner
2022 (San Diego) Annual Meeting

Founders Lecture
The Time is Now to Fix the Evidence Generation System

Mithat Gönen
2022 (San Diego) Annual Meeting

Presidential Welcome

Dr. Worta McCaskill-Stevens
2022 (San Diego) Annual Meeting

Curtis Meinert Lecture
Lessons Learned From the National Cancer Institute's Community Based Clinical Trials

Arsenio Paez
2022 (San Diego) Annual Meeting

Contributed Session
The Effects of Preceding Prospective Collaborative Studies (IDEAL Stage 2b) on the Quality and Impact of Subsequent Randomized Controlled Trials (IDEAL Stage 3) Evaluating Surgical Innovations: A Systematic Review and Case-Control Study

Session Details

Annabelle South
2022 (San Diego) Annual Meeting

Contributed Session
Communicating Overall Results to Trial Participants: The Perspective of Site Staff from the Show RESPECT Study

Session Details

Christin Hoffmann
2022 (San Diego) Annual Meeting

Contributed Session
A Core Information Set to Guide Early Phase Surgical Research

Session Details

Annabelle South
2022 (San Diego) Annual Meeting

Contributed Session
Effectiveness of Interventions to Share Trial Results with Health Workers and Policymakers: Results of a Systematic Review

Session Details

Zhibao Mi
2022 (San Diego) Annual Meeting

Contributed Session
Statistical Assessment of Unplanned Crossover Effect in Surgical Trials

Session Details

Jun Yin
2022 (San Diego) Annual Meeting

Contributed Session
Multi-Arm Multi-Outcome Clinical Trial Design and Analysis with Bayesian Spike-and-Slab Priors

Session Details

Daniel Schwartz
2022 (San Diego) Annual Meeting

Contributed Session
Dynamic Borrowing from Historical Controls via the Synthetic Prior with Covariates in Randomized Clinical Trials

Session Details

Samuel Sarkodie
2022 (San Diego) Annual Meeting

Contributed Session
A Hybrid Approach to Comparing Parallel-Group and Stepped-Wedge Cluster Randomized Trials When There is Uncertainty in the Intra-Cluster Correlation

Session Details

Clement Ma
2022 (San Diego) Annual Meeting

Contributed Session
Landscape of Phase 2 Trials in Alzheimer’s Disease: A Systematic Review of Trial Characteristics

Session Details

Christin Hoffmann
2022 (San Diego) Annual Meeting

Contributed Session
Modifications to Surgical Procedures: A Scoping Review and Preliminary Framework to Promote Transparent Reporting and Efficient Sharing

Session Details

Chengwu Yang
2022 (San Diego) Annual Meeting

Contributed Session
The CREID: Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Design, with Illustrations of One Published and Two Proposed Large Studies for Sequential and Parallel Designs

Session Details

Mark Harrison
2022 (San Diego) Annual Meeting

Contributed Session
Involving Patients in the Design of Randomized Clinical Trials

Session Details

Caitlin Thomas
2022 (San Diego) Annual Meeting

Contributed Session
Predicting Patients’ Willingness to Participate in Clinical Trials: A Simulation Tool Using Patient Choice Data

Session Details

Yun Qing
2022 (San Diego) Annual Meeting

Contributed Session
A Bayesian Piecewise Exponential Phase II Design for Monitoring a Time-to-Event Endpoint

Session Details

Yongming Qu
2022 (San Diego) Annual Meeting

Contributed Session
Collection of Precise Reasons for Treatment Discontinuations to Allow Better Defining Estimands

Session Details

Mayumi Fukuda-Doi
2022 (San Diego) Annual Meeting

Contributed Session
Developing At-A-Glance Workflows for Conducting Trials in Compliance with Complex Regulatory Systems and Expectations for Simplification of the System in Japan

Session Details

Hongli Li
2022 (San Diego) Annual Meeting

Contributed Session
A Non-Factorial Analysis of a Factorial Phase II Trial Design to Evaluate Single Agent and Combination Consolidation Therapies Following CD19 CAR T-cell Therapy for Relapsed/Refractory Diffuse Large B cell Lymphoma (R/R DLBCL): SWOG-S2114

Session Details

Fei Yuan
2022 (San Diego) Annual Meeting

Contributed Session
Stopping Rules of Interim Monitoring Analyses in Clinical Trials

Session Details

Christin Hoffmann
2022 (San Diego) Annual Meeting

Contributed Session
Automated Real-Time Monitoring and Feedback of Shared Decision Making for Surgery: A Non-Randomised Feasibility Study

Session Details

Fernando Santos Sanchez
2022 (San Diego) Annual Meeting

Contributed Session
A Novel Approach Employing Readability Metrics and Crowdsourcing to Improve Randomised Clinical Trial Information Leaflets

Session Details

Yongxi Long
2022 (San Diego) Annual Meeting

Contributed Session
A Bayesian Exact Adaptive Platform Design with Continual Reassessment for Trials Utilizing Real World Data

Session Details

Oleksandr Savenkov
2022 (San Diego) Annual Meeting

Contributed Session
A Comprehensive Simulation Study to Compare Estimators of Restricted Mean Survival Time Using Data from Clinical Trials

Session Details

Cristina Murray-Krezan
2022 (San Diego) Annual Meeting

Contributed Session
A Culturally and Contextually Situated Multimedia Approach to Recruiting, Consenting, and Randomizing a Hard-to-Reach Spanish-Speaking Population for a Randomized Controlled Trial

Session Details

Chris Cook
2022 (San Diego) Annual Meeting

Contributed Session
A More Efficient Approach to Clinical Trial Data Collection: The SWOG-nCartes Pilot Collaboration

Session Details

Gabrielle Murashova
2022 (San Diego) Annual Meeting

Session Proposal
A Partnership between Clinical Safety and Statistics for Aggregate Safety Assessment –Year Two

Session Details

Letitia Perdue
2022 (San Diego) Annual Meeting

Session Proposal
A Pragmatic Path to Direct Delivery of Drug to Participants

Session Details

Sasha Kravets
2022 (San Diego) Annual Meeting

Contributed Session
A RSHINY APPLET for Sequential, Multiple Assignment, Randomized Trials with a Time-to-Event Final Endpoint

Session Details

Ying Zhang
2022 (San Diego) Annual Meeting

Contributed Session
A SAS Macro for the Power of Generalized Estimating Equations Analysis of Cluster Randomized Trials with the Application to Stepped Wedge Designs

Session Details

Evan Kwiatkowski
2022 (San Diego) Annual Meeting

Contributed Session
A Structured Framework for Adaptively Incorporating External Evidence in Sequentially Monitored Clinical Trials

Session Details

Zhuopei Hu
2022 (San Diego) Annual Meeting

Contributed Session
A Web Application Tool for Power Calculation of Stepped Wedge Cluster Randomization Trials with Complete/Incomplete Design

Session Details

Kimberly Carlson
2022 (San Diego) Annual Meeting

Session Proposal
Accommodating “History Effects” in Long Duration, Multi-Site Clinical Trials to Ensure Relevant and Compelling Evidence

Session Details

Shun Fu Lee
2022 (San Diego) Annual Meeting

Contributed Session
Accounting for Correlation Among the Total Events of Composite Outcomes in Cardiovascular Trials

Session Details

Richard Emsley
2022 (San Diego) Annual Meeting

Contributed Session
Accounting for Differential Uptake of Treatment-as-Usual in Open-Label RCTs: A Comparison of Methods and Illustration in Mental Health Trials

Session Details

Guangyu Tong
2022 (San Diego) Annual Meeting

Contributed Session
Accounting for Unequal Cluster Sizes in Designing Cluster Randomized Trials to Detect Treatment Effect Heterogeneity

Session Details

Marcus Johnson
2022 (San Diego) Annual Meeting

Contributed Session
Addressing Challenges and Barriers to Rural Veteran Participation in Clinical Research Within the Veterans Affairs Healthcare System

Session Details

Richard Henry
2022 (San Diego) Annual Meeting

Contributed Session
Advantages, Disadvantages, and Other Considerations for Trials in Cohorts: A Decade In

Session Details

David Zahrieh
2022 (San Diego) Annual Meeting

Contributed Session
Allowing for Uncertainty in the Components Required for Sample Size Estimation for a Cluster Randomized Trial Using the Symbolic Two-Step Method

Session Details

Richard Emsley
2022 (San Diego) Annual Meeting

Session Proposal
Analysing Clinical Trials Disrupted by the COVID-19 Pandemic

Session Details

Lu Mao
2022 (San Diego) Annual Meeting

Session Proposal
Analysis of Complex Time-to-Event Endpoints in Clinical Trials

Session Details

Tyler Bonnett
2022 (San Diego) Annual Meeting

Session Proposal
Bad Bugs in Tough Places – Developing Capacity to Obtain Compelling Evidence in Challenging Environments

Session Details

Travis Lilley
2022 (San Diego) Annual Meeting

Contributed Session
Bayesian Analysis of Cluster Randomized Trials with Ordinal Endpoints

Session Details

Fang Fang
2022 (San Diego) Annual Meeting

Contributed Session
Bayesian Methods to Compare Dose Levels to Placebo in a small n, Sequential, Multiple Assignment, Randomized Trial (snSMART) with a Continuous Outcome

Session Details

Azzolina Danila
2022 (San Diego) Annual Meeting

Contributed Session
Bayesian Network Enforced Super Learner Treatment Effect Estimation in Clinical Trial: A Proposal and Application

Session Details

Lianlian Du
2022 (San Diego) Annual Meeting

Contributed Session
Bayesian Random Change Point Mixed Model Analysis of Cognitive Performance Trajectories to Identify Eligible Patients for Randomized Clinical Trials

Session Details

Anda Dragomir
2022 (San Diego) Annual Meeting

Educational Session
Behavioural Trial Design: Using Stakeholder-Driven Processes to Develop Interventions and Assessment Tools Using a Public Health Intervention Example

Session Details

Menelaos Konstantinidis
2022 (San Diego) Annual Meeting

Contributed Session
Benefits and Pitfalls of Combining Observational and Experimental Studies in Network Meta-Analyses: Implications for Public Health Policy

Session Details

Paola Berchialla
2022 (San Diego) Annual Meeting

Contributed Session
Benefits and Risks in Leveraging Historical Control Data in Clinical Trials

Session Details

Ileana Baldi
2022 (San Diego) Annual Meeting

Contributed Session
Building Infrastructure to Exploit Evidence from Patient Preference Information (PPI) Studies

Session Details

Chuck Huber
2022 (San Diego) Annual Meeting

Educational Session
Causal Inference for Complex Data

Session Details

Danielle Edwards
2022 (San Diego) Annual Meeting

Contributed Session
Challenges for Conducting Mediation Analyses in Multi-Arm Trials

Session Details

Elizabeth Avery
2022 (San Diego) Annual Meeting

Contributed Session
Challenges Implementing a Clustered Randomized Behavioral Clinical Trial in a Community Based Participatory Research Framework

Session Details

Kevin Buhr
2022 (San Diego) Annual Meeting

Educational Session
Clinical Trial Data Monitoring Committees and Reporting Statistical Centers: The Basics and Emerging Issues

Session Details

Marcus Johnson
2022 (San Diego) Annual Meeting

Contributed Session
Clinical Trial Facilitators: A Novel Approach to Support the Execution of Clinical Research at the Study Site Level

Session Details

Wendy Seiferheld
2022 (San Diego) Annual Meeting

Contributed Session
ClinicalTrials.gov Tracking with Do-It-Yourself Application Programming Interface (DIY API)

Session Details

Anca Chis Ster
2022 (San Diego) Annual Meeting

Contributed Session
Combining Non-Adherence and Mediation in a Unified Causal Analysis: A Methodological Review and Application to the AVATAR Trial

Session Details

Heng Zhou
2022 (San Diego) Annual Meeting

Session Proposal
Complex Innovative Design in the Modern Drug Development Era

Session Details

Victoria Shepherd
2022 (San Diego) Annual Meeting

Contributed Session
Conceptualising ‘Good’ Proxy Consent Decisions for Clinical Trial Participation: Implications for the Development of Interventions to Improve the Quality of Proxy Consent

Session Details

Hayley Belli
2022 (San Diego) Annual Meeting

Contributed Session
Considerations When Collecting Real World Data in Expanded Access Programs

Session Details

Christina Bucci-Rechtweg
2022 (San Diego) Annual Meeting

Contributed Session
Correcting Disparities In Adolescent Access To Medicines By Promoting Age-Inclusive Research

Session Details

Andrew Hall
2022 (San Diego) Annual Meeting

Contributed Session
Decision making under uncertainty in PI-II dose finding trials in Oncology

Session Details

Jody Ciolino
2022 (San Diego) Annual Meeting

Educational Session
Demystifying Statistics in Clinical Trials

Session Details

Fan Li
2022 (San Diego) Annual Meeting

Session Proposal
Design and Analysis of Stepped Wedge Cluster Randomized Trials Based on Marginal Models for Discrete and Continuous Outcomes

Session Details

Sheng luo
2022 (San Diego) Annual Meeting

Educational Session
Design Clinical Trials with Non-Inferiority Hypothesis: Methods and Applications

Session Details

Jonathan Beall
2022 (San Diego) Annual Meeting

Session Proposal
Developing Adaptive Trial Designs: A Collaborative Process Balancing Statistical Efficiency with Clinical Importance

Session Details

Harry Parr
2022 (San Diego) Annual Meeting

Contributed Session
Developing and Externally Validating Clinical Dynamic Prediction Joint Models for Localised Prostate Cancer

Session Details

Victoria Shepherd
2022 (San Diego) Annual Meeting

Contributed Session
Development of a Core Outcome Set for the Evaluation of Interventions to Enhance Proxy Consent Decisions on Behalf of Adults who Lack Capacity to Consent: A Mixed Methods Study (COnSiDER Study)

Session Details

Mat Makowski
2022 (San Diego) Annual Meeting

Contributed Session
Disseminating Phase I Vaccine Trial Data in a Pandemic to Inform the Scientific Community – mRNA-1273 Phase I Trials

Session Details

Shawn Hirsch
2022 (San Diego) Annual Meeting

Contributed Session
Do Participants Exhibit Evidence of Respondent Fatigue After Completion of Subjective Questionnaires Multiple Times Across a Study?: Examination of Data from a Phase I Inpatient Randomized Clinical Trial

Session Details

Kentaro Takeda
2022 (San Diego) Annual Meeting

Session Proposal
Dose Optimization in Oncology: Why, When and How

Session Details

Lauren Shirley
2022 (San Diego) Annual Meeting

Contributed Session
Dotting Your I's and Crossing Your T's: An Informed Consent Documentation Tool for Clinical Trials

Session Details

Yves Rosenberg
2022 (San Diego) Annual Meeting

Educational Session
Essentials of Clinical Trials

Session Details

Chia-Rui (Jerry) Chang
2022 (San Diego) Annual Meeting

Contributed Session
Estimating Marginal Treatment Effect in Cluster Randomized Trials with Multilevel Missing Outcomes

Session Details

Wenjing Meng
2022 (San Diego) Annual Meeting

Contributed Session
Estimating the Impact of Patient Preference in Two-Stage Clinical Trials for Binary Outcomes When Some Patients are Indifferent to Treatment

Session Details

Richard Emsley
2022 (San Diego) Annual Meeting

Contributed Session
Estimation of personalised treatment recommendations in the survival context using a restricted mean survival time outcome

Session Details

Emily Roberts
2022 (San Diego) Annual Meeting

Contributed Session
Evaluating Intermediate Clinical Endpoints for Futility Analysis in Clinical Trials

Session Details

Christina Bucci-Rechtweg
2022 (San Diego) Annual Meeting

Contributed Session
Grownish: How And When To Include Adolescents In Adult Research

Session Details

Katie Mellor
2022 (San Diego) Annual Meeting

Contributed Session
How are Progression Decisions Made Following External Randomised Pilot Trials? A Qualitative Interview Study and Framework Analysis

Session Details

Peyton Kline
2022 (San Diego) Annual Meeting

Session Proposal
How Different Communication Pathways Impact the Success of a Clinical Trial, A Multifaceted Perspective

Session Details

Nick Beckley-Hoelscher
2022 (San Diego) Annual Meeting

Contributed Session
How Much is that Data in the Window? A Comparison of Strategies for Analysing Data Recorded Outside Pre-Specified Visit Windows in Randomised Controlled Trials

Session Details

Lisa Eckstein
2022 (San Diego) Annual Meeting

Contributed Session
Identifying and Examining Ethical Considerations Facing Data Monitoring Committees

Session Details

Minji Lee
2022 (San Diego) Annual Meeting

Contributed Session
Identifying Meaningful Change on PROMIS Short Forms in Cancer Patients: A Comparison of Item Response Theory and Classic Test Theory Frameworks

Session Details

Adam Resnick
2022 (San Diego) Annual Meeting

Contributed Session
Implementation of Platform-Enabled Fast Healthcare Interoperability Resources on Behalf of Empowered, Accelerated Discovery in Children with SARS-CoV-2 Infections

Session Details

Heidi Krause-Steinrauf
2022 (San Diego) Annual Meeting

Contributed Session
Implementation of Substudies in Multi-Center Clinical Trials: The Grade Study Experience

Session Details

Danielle Edwards
2022 (San Diego) Annual Meeting

Contributed Session
Implementing Personalised Treatment Recommendations to Determine Optimal Treatment Decisions Using Data from a Three-Arm Trial When Both Active Treatments Show Positive Results

Session Details

Emily Dressler
2022 (San Diego) Annual Meeting

Session Proposal
Improving Data Quality in Multi-Center Trials: Innovative Approaches Utilized within the Wake Forest NCI Community Oncology Research Program Research Base (WF NCORP RB)

Session Details

Michael Rosenblum
2022 (San Diego) Annual Meeting

Educational Session
Improving Precision and Power in Randomized Trials by Leveraging Baseline Variables

Session Details

Katie Mellor
2022 (San Diego) Annual Meeting

Contributed Session
Inclusion of Progression Criteria in External Randomised Pilot Trial Funding Applications Submitted to UK NIHR Research for Patient Benefit

Session Details

Allyn Bove
2022 (San Diego) Annual Meeting

Session Proposal
Inclusive Recruitment Strategies in Clinical Trials: Insights from Rehabilitation Research

Session Details

Emine Bayman
2022 (San Diego) Annual Meeting

Contributed Session
Increasing the Generalizability of Pain Study Results

Session Details

Kathryn Hefner
2022 (San Diego) Annual Meeting

Session Proposal
Innovative Approaches to Data Collection Needs in Clinical Trials: Considerations, Lessons Learned and Future Directions

Session Details

Julie Croft
2022 (San Diego) Annual Meeting

Contributed Session
Integration of Qualitative Research Into Surgical Trials to Optimise Trial Conduct and Understanding of the Trial Results For Maximal Impact

Session Details

Anna Bosse
2022 (San Diego) Annual Meeting

Contributed Session
Interim Data Communication Strategies for Adaptive Clinical Trial Designs

Session Details

Jonathan Beall
2022 (San Diego) Annual Meeting

Contributed Session
Interpreting a Bayesian Phase II Futility Clinical Trial

Session Details

Abigail Baldridge
2022 (San Diego) Annual Meeting

Educational Session
Introduction to Efficient Preparation, Access, and Sharing of Trial Data in REDCap Using the API

Session Details

Laura Lovato
2022 (San Diego) Annual Meeting

Educational Session
It Takes a Village: Multi-Disciplinary Approach to Designing Stellar Data Collection Forms

Session Details

Kathryn Arnold
2022 (San Diego) Annual Meeting

Contributed Session
Lessons from Implementing Practice-Level Cluster Randomized Studies within the NCORP Setting

Session Details

Danielle Cunio
2022 (San Diego) Annual Meeting

Contributed Session
Letter Tracking System Design: The Systolic Blood Pressure Intervention Trial Mind 2020

Session Details

Katelyn Garcia
2022 (San Diego) Annual Meeting

Contributed Session
Lifestyle Intervention Delivery During the COVID Era

Session Details

Wei Wei
2022 (San Diego) Annual Meeting

Contributed Session
Local Multisource-Exchangeability Model for Adaptive Information Borrowing from Multiple Historical Controls

Session Details

Mary Ryan
2022 (San Diego) Annual Meeting

Contributed Session
Maximin Optimal Cluster Randomized Designs Accounting for Treatment Effect Heterogeneity

Session Details

Ying Yuan
2022 (San Diego) Annual Meeting

Educational Session
Model-Assisted Designs: Make Adaptive Clinical Trials Easy and Accessible

Session Details

Aditya Pabba
2022 (San Diego) Annual Meeting

Contributed Session
Novel Method of Using JavaScript Encoding and QR (Quick Response) Codes in Remotely Managed Randomization of Blinded Studies in Low-Resource Environments

Session Details

Eleanor McFadden
2022 (San Diego) Annual Meeting

Contributed Session
OlympiA – A Complex but Successful Model for a Large Global Trial

Session Details

Bingkai Wang
2022 (San Diego) Annual Meeting

Contributed Session
On the Robustness and Precision of Mixed-Model Analysis of Covariance in Cluster-Randomized Trials

Session Details

Shaun Bulsara
2022 (San Diego) Annual Meeting

Contributed Session
OnCore and REDCap: A Comparison of Two Data Management Systems

Session Details

Brian Neumann
2022 (San Diego) Annual Meeting

Contributed Session
One Line on a Manuscript: Operationalizing Ecological Momentary Assessment (EMA) in Clinical Trials

Session Details

Andrea Arfe
2022 (San Diego) Annual Meeting

Contributed Session
Optimality of Testing Procedures for Survival Data in the Non-Proportional Hazards Setting

Session Details

Brigitte Voisard
2022 (San Diego) Annual Meeting

Contributed Session
Optimization of a Training Program in Motivational Communication: Phase 1

Session Details

Pam Mangat
2022 (San Diego) Annual Meeting

Session Proposal
Optimizing Precision Medicine Cancer Clinical Trials

Session Details

Roger Lewis
2022 (San Diego) Annual Meeting

Session Proposal
Optimizing the Interdisciplinary Design of Adaptive Platform Trials

Session Details

Audinga-Dea Hazewinkel
2022 (San Diego) Annual Meeting

Contributed Session
Outcome Variance After Dropout as an Indicator of Missing-Not-At-Random Bias in Randomized Clinical Trials

Session Details

Rachelle Swann
2022 (San Diego) Annual Meeting

Contributed Session
Overview of CDER BIMO Compliance and Enforcement

Session Details

Daisy Gaunt
2022 (San Diego) Annual Meeting

Contributed Session
Participant Retention in Pediatric Randomized Controlled Trials: Systematic Review and Meta-Analysis

Session Details

Hayley Belli
2022 (San Diego) Annual Meeting

Session Proposal
Perspectives on Real World Data and Evidence Collection Through Expanded Access

Session Details

Yisheng Li
2022 (San Diego) Annual Meeting

Session Proposal
Pharmacokinetics and/or Pharmacodynamics-Informed Dose-Finding Designs

Session Details

Jane Hongyuan Zhang
2022 (San Diego) Annual Meeting

Session Proposal
Planning, Prioritizing, and Conducting Clinical Research in the VA Learning Healthcare System During the COVID-19 Pandemic

Session Details

Kendra Plourde
2022 (San Diego) Annual Meeting

Contributed Session
Power Analysis for Stepped Wedge Cluster Randomized Trials with Continuous Co-Primary Endpoints

Session Details

Navneet Hakhu
2022 (San Diego) Annual Meeting

Contributed Session
Quantifying the Impact of Enrichment in Pre-Post Randomized Controlled Clinical Trials

Session Details

Azzolina Danila
2022 (San Diego) Annual Meeting

Contributed Session
Quantifying the Prior Informativeness via ESS Approach in a Clinical Trial: An Application of a Semiparametric Prior Elicitation Phase IIA Design

Session Details

Jason Haukoos
2022 (San Diego) Annual Meeting

Contributed Session
Randomization Schemes Using Electronic Health Systems to Facilitate Emergency Department-Based Pragmatic Clinical Trials of Public Health Screening Interventions

Session Details

Christina Saunders
2022 (San Diego) Annual Meeting

Session Proposal
Real World Experience in Conducting Adaptive Platform Trials

Session Details

Daisy Gaunt
2022 (San Diego) Annual Meeting

Contributed Session
Retention to pediatric randomized controlled trials during the COVID-19 pandemic: a qualitative study

Session Details

Laura Levit
2022 (San Diego) Annual Meeting

Session Proposal
Rethinking the Inclusion of Research Biopsies in the Design of Clinical Trials

Session Details

Songthip Ounpraseuth
2022 (San Diego) Annual Meeting

Contributed Session
Statistical Considerations for Testing Facility Interventions in Infants with Neonatal Opioid Withdrawal Syndrome (NOWS)

Session Details

Katie Gillies
2022 (San Diego) Annual Meeting

Contributed Session
Strategies to Improve Retention in Randomised Trials: A Cochrane Review

Session Details

Heidi Krause-Steinrauf
2022 (San Diego) Annual Meeting

Session Proposal
Strategies to Mitigate the Impact of the COVID Pandemic on Trial Implementation, Closeout, Data Quality and Analysis of a Large Multicenter Clinical Trial: The Glycemia Reduction Approaches in Diabetes Comparative Effectiveness Study (GRADE)

Session Details

Azzolina Danila
2022 (San Diego) Annual Meeting

Contributed Session
SuperLearner Enforced Treatment Effect Estimation in Pediatric Trials

Session Details

Cherish Boxall
2022 (San Diego) Annual Meeting

Contributed Session
SWAT Priorities to Improve the Evidence to Inform Recruitment and Retention Practice in Clinical Trials

Session Details

Jieling Miao
2022 (San Diego) Annual Meeting

Contributed Session
The Application of ACCEPT Software in Retrospective Analysis of Specimen Data (SWOG S0500 Translational Medicine Project)

Session Details

Kim May Lee
2022 (San Diego) Annual Meeting

Contributed Session
The Benefits of Covariate Adjustment for Adaptive Multi-Arm Designs

Session Details

David Bryde
2022 (San Diego) Annual Meeting

Contributed Session
The CURED Framework: A Data-Driven Management Tool to Aid Successful Delivery of Clinical Research Projects

Session Details

Corinne McGill
2022 (San Diego) Annual Meeting

Contributed Session
The Effect of Subject Accrual on Futility Analyses in Randomized Clinical Trials with Time-To-Event Endpoints: A Simulation Study on Conditional Power

Session Details

Xiangrong Kong
2022 (San Diego) Annual Meeting

Session Proposal
The Estimand Framework from the ICH E9(R1) Statistical Principles for Clinical Trials Addendum: Current Implementation Status and Looking Forward

Session Details

Mollie Payne
2022 (San Diego) Annual Meeting

Contributed Session
The Good, The Bad and The Hidden Bias in Mediation Analyses of Clinical Trials

Session Details

Ellen Kingsley
2022 (San Diego) Annual Meeting

Contributed Session
The I-SOCIALISE Study: A Cluster Randomised Controlled Trial Investigating the Social Competence and Isolation of Children with Autism Taking Participating in LEGO® Based Therapy (‘Play Brick Therapy’) Groups in Mainstream School Environments

Session Details

Joseph Rausch
2022 (San Diego) Annual Meeting

Contributed Session
The Inclusion of Covariates in Constrained Longitudinal Data Analysis for Pre-Post Randomized Clinical Trials

Session Details

John Nichols
2022 (San Diego) Annual Meeting

Contributed Session
The Intervention Portal: Consolidating Study Intervention Tracking with Participant Data Management

Session Details

Larisa Tereshchenko
2022 (San Diego) Annual Meeting

Educational Session
The Legacy of Tuskegee and Ethics of Clinical Trials

Session Details

Cory Goldstein
2022 (San Diego) Annual Meeting

Contributed Session
The Problem of Identifying Vulnerable Research Participants in Pragmatic Cluster Randomized Trials

Session Details

Cody Chiuzan
2022 (San Diego) Annual Meeting

Session Proposal
The Promise and Challenges of Integrating Real-World Evidence in Clinical Research

Session Details

Julia Collins
2022 (San Diego) Annual Meeting

Contributed Session
The Protocol Review Checklist: A Tool to Ensure Protocol Completeness, Consistency, and Accuracy

Session Details

Yi Dai
2022 (San Diego) Annual Meeting

Contributed Session
The Use of Evidence-Based Dynamic Treatment Regimes to Improve Depression Outcomes

Session Details

Katie Gillies
2022 (San Diego) Annual Meeting

Contributed Session
The What, How, When and Who of Sharing Trial Results Summaries with Trial Participants: Stakeholder Informed Guidance from the RECAP Project

Session Details

Dario Gregori
2022 (San Diego) Annual Meeting

Contributed Session
The Win-Ratio Approach. Some Notes on the Impact of Unbalanced Samples, Heterogeneity, and Clustering in Data

Session Details

Neil Corrigan
2022 (San Diego) Annual Meeting

Contributed Session
Trial Designs to Target the Conditional Average Treatment Effect, with Application to Operating Surgeon Learning Effects in Surgical RCTS

Session Details

Lawrence Mbuagbaw
2022 (San Diego) Annual Meeting

Educational Session
TrialTree: A Novel Application for Interactive Trial Design

Session Details

Jose Luis Olmos- Serrano
2022 (San Diego) Annual Meeting

Contributed Session
TwinRCT: Leveraging External Data, Artificial Intelligence, and Covariate Adjustment

Session Details

Victoria Shepherd
2022 (San Diego) Annual Meeting

Contributed Session
Unpacking the ‘Black Box of Horrendousness’: A Qualitative Study Exploring the Barriers and Facilitators to Conducting Trials Involving Adults Lacking Capacity to Consent

Session Details

Tina Neill-Hudson
2022 (San Diego) Annual Meeting

Session Proposal
Using a Single IRB for NIH-Funded Multisite Trials

Session Details

Maiken Pontoppidan
2022 (San Diego) Annual Meeting

Contributed Session
Using Informational Videos to Support Recruitment for Parenting Trials

Session Details

Gail Potter
2022 (San Diego) Annual Meeting

Contributed Session
Using Social Contact Data to Improve the Overall Effect Estimate of a Cluster-Randomized Influenza Vaccination Program in Senegal

Session Details

Heejoon Ahn
2022 (San Diego) Annual Meeting

Contributed Session
Utilization of R Markdown for Automation in Development of Participant Feedback Reports for N-of-1 Trial Designs

Session Details

Anda Dragomir
2022 (San Diego) Annual Meeting

Contributed Session
Validation of a New Digital Tool to Assess Physician Competency in Behaviour Change Counseling: The Motivational Communication Competency Assessment Test

Session Details

Mitchell Paukner
2022 (San Diego) Annual Meeting

Contributed Session
Versatile Window Mean Survival Time: Motivating Trial Design and Analysis with Clinical Relevance

Session Details

Kelly Van Lancker
2022 (San Diego) Annual Meeting

Session Proposal
When and How to Use Covariate Adjustment to Improve Precision in Randomized Trials

Session Details

Kieran O'Brien
2021 (Virtual) Annual Meeting

Contributed Session
The effect of targeting biannual azithromycin distribution by age group on mortality and resistance in Niger: design of an adaptive cluster-randomized large simple trial (AVENIR)

Session Details

Emily Rives
2021 (Virtual) Annual Meeting

Contributed Session
Dynamic Scoring and Guided Data Entry in a Tele-Health Cognitive Battery

Session Details

Gillian Gresham
2021 (Virtual) Annual Meeting

Contributed Session
Evaluating the effect of a mobile audio companion to reduce feelings of distress and loneliness in cancer patients during COVID-19 (COMPANION Trial)

Session Details

Rachel Phillips
2021 (Virtual) Annual Meeting

Contributed Session
Recommendations for visualising the drug harm profile in Randomised Controlled Trials: a consensus

Session Details

Zibo Tian
2021 (Virtual) Annual Meeting

Contributed Session
IMPACT OF UNEQUAL CLUSTER SIZES FOR GENERALIZED ESTIMATING EQUATION ANALYSES OF STEPPED WEDGE DESIGNS WITH BINARY OUTCOMES

Session Details

Lindsay Kehoe
2021 (Virtual) Annual Meeting

Contributed Session
Improving Efficiency by Embedding Trials into Health Care Settings

Session Details

Shelley Vanderhout
2021 (Virtual) Annual Meeting

Contributed Session
PREVALENCE OF AND FACTORS ASSOCIATED WITH PATIENT-REPORTED OUTCOMES IN PRAGMATIC RANDOMIZED CONTROLLED TRIALS

Session Details

Min Zhan
2021 (Virtual) Annual Meeting

Contributed Session
CONSIDERATIONS IN IMPLEMENTING THE ESTIMAND FRAMEWORK IN MULTISITE RANDOMIZED CLINICAL TRIALS

Session Details

Eileen Stock
2021 (Virtual) Annual Meeting

Contributed Session
An Efficient Centralized Statistical Monitoring Program to Improve Data Integrity of Multicenter Clinical Trials

Session Details

Neal Oden
2021 (Virtual) Annual Meeting

Contributed Session
Number of Strata in Clinical Trial Design and Its Impact on Treatment Imbalance

Session Details

Monica Taljaard
2021 (Virtual) Annual Meeting

Contributed Session
HOW ARE CLAIMS OF PRAGMATISM JUSTIFIED IN PRIMARY TRIAL REPORTS? RESULTS FROM A REVIEW OF 415 SELF-DECLARED PRAGMATIC TRIALS

Session Details

Ashley Tjaden
2021 (Virtual) Annual Meeting

Contributed Session
Motivation for participation in a clinical trial among youth and adults with prediabetes or recently diagnosed type 2 diabetes

Session Details

Jennifer Gassman
2021 (Virtual) Annual Meeting

Contributed Session
Use of Vanguard Enrollment to demonstrate feasibility of a high-enrollment surgical trial: The Safe Cholecystectomy OUTcomes (SCOUT) Clinical Trial of Laparoscopic Cholecystectomy (LC)

Session Details

Holly Shaw
2021 (Virtual) Annual Meeting

Contributed Session
Centralized Remote and Risk-Based Monitoring in the INVESTED Trial: a Cost-Effective and Easy-to-Implement Approach

Session Details

Daniele Farrisi
2021 (Virtual) Annual Meeting

Contributed Session
Research Ready: Strategies for Successful Implementation of Research in Clinical Settings

Session Details

Peter McCulloch
2021 (Virtual) Annual Meeting

Contributed Session
Using IDEAL to evaluate research waste in surgery more realistically.

Session Details

Harry Parr
2021 (Virtual) Annual Meeting

Contributed Session
DEVELOPING AND VALIDATING CLINICAL DYNAMIC PREDICTION JOINT MODELS TO PREDICT PROGNOSIS IN PROSTATE CANCER PATIENTS

Session Details

Paola Berchialla
2021 (Virtual) Annual Meeting

Contributed Session
Prediction of treatment outcome and heterogeneous treatment effect in clinical trials: a machine learning approach

Session Details

Leah Pirondini
2021 (Virtual) Annual Meeting

Contributed Session
Covariate adjustment in cardiovascular randomised controlled trials: a review of current practice and simulation studies

Session Details

Lara Maleyeff
2021 (Virtual) Annual Meeting

Contributed Session
Estimating treatment effect heterogeneity in stepped wedge cluster randomized trials with binary outcomes

Session Details

Georgine Price
2021 (Virtual) Annual Meeting

Contributed Session
SITE MONITORING AND SITE MANAGEMENT DURING COVID-19 - A CONTRACT RESEARCH ORGANIZATION’S EXPERIENCE

Session Details

Mitra Lewis
2021 (Virtual) Annual Meeting

Contributed Session
Electronic Data Capture (EDC) system modifications to capture COVID-19 related data in the National Drug Abuse Treatment Clinical Trial Network (NDAT CTN)

Session Details

Monica Taljaard
2021 (Virtual) Annual Meeting

Contributed Session
REPORTING OF INFORMED CONSENT IN PRAGMATIC TRIALS: RESULTS FROM A SYSTEMATIC LITERATURE SURVEY

Session Details

Dario Gregori
2021 (Virtual) Annual Meeting

Contributed Session
The challenge of the COVID-19 pandemic faced by Italian ethics committees: a research survey

Session Details

Giles Partington
2021 (Virtual) Annual Meeting

Contributed Session
The Design and Analysis of Small Population and Rare Disease Trials: A Review of Randomised Trials

Session Details

Daniel Schwartz
2021 (Virtual) Annual Meeting

Contributed Session
Fast and Informative Phase 2b Dose-ranging Trials Using Bayesian Uncertainty-Directed Designs with Model Averaging

Session Details

Emily Roberts
2021 (Virtual) Annual Meeting

Contributed Session
Incorporating Baseline Covariates to Validate Surrogate Endpoints with a Constant Biomarker under Control Arm

Session Details

Matthew Dodd
2021 (Virtual) Annual Meeting

Contributed Session
STATISTICAL METHODS FOR HANDLING NON-ADHERENCE TO INTERVENTIONS IN RANDOMISED NON-INFERIORITY TRIALS: A SYSTEMATIC REVIEW

Session Details

Victoria Cornelius
2021 (Virtual) Annual Meeting

Contributed Session
Improving the analysis of adverse event data in randomised controlled trials

Session Details

Matthew Gooden
2021 (Virtual) Annual Meeting

Contributed Session
Determining the Optimal Percent of Research Records to Review: Reducing the Variability in Audits with Human Research Participants

Session Details

Sharon Love
2021 (Virtual) Annual Meeting

Contributed Session
Making a distinction between data cleaning and central monitoring

Session Details

Lara Philipps
2021 (Virtual) Annual Meeting

Contributed Session
Study within a trial comparing electronic versus paper patient reported outcome collection

Session Details

Diana Papaioannou
2021 (Virtual) Annual Meeting

Contributed Session
Adverse event recording fails to reflect potential harms: A review of trial protocols of behavioural, lifestyle and psychological therapy interventions.

Session Details

Rebecca Silva
2021 (Virtual) Annual Meeting

Contributed Session
Would the recommended dose have been different using novel dose-finding designs? Comparing dose-finding designs in published trials.

Session Details

Xueqi Wang
2021 (Virtual) Annual Meeting

Contributed Session
Power considerations for generalized estimating equations analyses of four-level designs

Session Details

Martin Law
2021 (Virtual) Annual Meeting

Contributed Session
Multi-outcome trials with a generalised number of efficacious outcomes

Session Details

Katie Mellor
2021 (Virtual) Annual Meeting

Contributed Session
PROGRESSION FROM EXTERNAL PILOT TO DEFINITIVE RANDOMISED CONTROLLED TRIAL ARE NOT ADEQUATELY REPORTED: A METHODOLOGICAL REVIEW OF PROGRESSION CRITERIA REPORTING

Session Details

Christina Fu
2021 (Virtual) Annual Meeting

Contributed Session
USE OF COMPREHENSIVE SOLICITED EVENT REPORTING FOR SAFETY MONITORING IN CLINICAL TRIALS WITH STANDARD OF CARE DRUGS

Session Details

Glory Koerbel
2021 (Virtual) Annual Meeting

Contributed Session
HOW CLINICAL TRIAL MANAGEMENT SYSTEMS CAN HELP REDUCE COORDINATOR BURDEN

Session Details

Zhibao Mi
2021 (Virtual) Annual Meeting

Contributed Session
Role of Electronic Health Records in VA CSP Multicenter Clinical Trials

Session Details

Gail Potter
2021 (Virtual) Annual Meeting

Contributed Session
Dismantling the Fragility Index: A Demonstration of Statistical Reasoning

Session Details

Phyllis Goodman
2021 (Virtual) Annual Meeting

Contributed Session
Actions of a National Oncology Group to Manage the Impact of the COVID-19 Pandemic

Session Details

Menelaos Konstantinidis
2021 (Virtual) Annual Meeting

Contributed Session
MULTI-AGENT AGREEMENT COEFFICIENTS: IMPLICATIONS FOR CLINICAL TRIALS OF DIAGNOSTIC TESTING

Session Details

Christin Hoffmann
2021 (Virtual) Annual Meeting

Contributed Session
MEASURING INNOVATION-SPECIFIC OUTCOMES IN STUDIES EVALUATING NEW SURGICAL PROCEDURES AND DEVICES: APPRAISAL AND RECOMMENDATION OF OUTCOME MEASUREMENT INSTRUMENTS USING MODIFIED COSMIN METHODOLOGY

Session Details

Douglas Lammie
2021 (Virtual) Annual Meeting

Contributed Session
Facilitating Study Collaboration in your Pajamas: Replicating a Virtual Office Space While Teleworking"

Session Details

Stuart Nicholls
2021 (Virtual) Annual Meeting

Contributed Session
THE IMPACT OF PATIENT ENGAGEMENT ON TRIALS AND TRIALISTS: AN INTERVIEW STUDY WITH IMPACT AWARDEES

Session Details

Gemma Ainsworth
2021 (Virtual) Annual Meeting

Contributed Session
CO-ENROLMENT OF PATIENTS IN TRIALS OF COMPLEX SURGICAL INTERVENTIONS: RECOMMENDATIONS FROM THE INTACT TRIAL

Session Details

Brian Burke
2021 (Virtual) Annual Meeting

Contributed Session
From Clinical Trial to Observational Study: Long-Term Retention in the TODAY and TODAY2 Studies

Session Details

Saskia Eddy
2021 (Virtual) Annual Meeting

Contributed Session
HOW BIG SHOULD MY PILOT STUDY BE? A METHODOLOGICAL REVIEW

Session Details

Ondrej Blaha
2021 (Virtual) Annual Meeting

Contributed Session
A Bayesian Exact Platform Design for Multi-arm, Phase II trials with Historical Control

Session Details

Kendra Davis-Plourde
2021 (Virtual) Annual Meeting

Contributed Session
Sample size calculation for stepped wedge cluster randomized trials with multiple levels of clustering

Session Details

Brian Burke
2021 (Virtual) Annual Meeting

Contributed Session
Developing an E-Consent System

Session Details

Alyssa Vanderbeek
2021 (Virtual) Annual Meeting

Contributed Session
Consequences of Phase I Dose Selection on Go/No-Go Decisions in Oncology Drug Development

Session Details

Mitchell Paukner
2021 (Virtual) Annual Meeting

Contributed Session
Window Mean Survival Time

Session Details

J Athene Lane
2021 (Virtual) Annual Meeting

Contributed Session
PATIENT AND PUBLIC INVOLVEMENT IN CLINICAL TRIALS: A MIXED METHODS STUDY IN A CLINICAL TRIALS UNIT TO IDENTIFY GOOD PRACTICE, BARRIERS AND FACILITATORS

Session Details

Madeleine Clout
2021 (Virtual) Annual Meeting

Contributed Session
Are Electronic Study Management Systems Acceptable to Participating Sites?

Session Details

Amy Sullivan
2021 (Virtual) Annual Meeting

Contributed Session
What is the (end) point?

Session Details

Joerg Hasford
2021 (Virtual) Annual Meeting

Contributed Session
There are too many p-values smaller 0.01 for clinically relevant primary endpoints reported in randomised trials - results from a systematic analysis of high impact publications

Session Details

Dario Gregori
2021 (Virtual) Annual Meeting

Contributed Session
The state-of-the-art of the Prior Elicitation method in clinical trial design and analysis: a literature review

Session Details

Christopher Schroth
2021 (Virtual) Annual Meeting

Contributed Session
The Record of Study Consultation (RSC): A Tool to Control, Document, & Streamline Sponsor Guidance

Session Details

Sheila Sprague
2021 (Virtual) Annual Meeting

Contributed Session
THE IMPACT OF COVID-19 RESTRICTIONS ON PARTICIPANT ENROLLMENT IN THE PREPARE TRIAL

Session Details

Mudathir Ibrahim
2021 (Virtual) Annual Meeting

Contributed Session
The effects of preceding prospective collaborative studies (IDEAL stage 2b) on the quality and impact of subsequent randomized controlled trials (IDEAL stage 3) evaluating surgical innovations. A case-control systematic review of the literature

Session Details

David Zahrieh
2021 (Virtual) Annual Meeting

Contributed Session
Symbolic two-step method compared with single-step methods to model the center mean outcome in cluster randomized trials

Session Details

Wei Wei
2021 (Virtual) Annual Meeting

Contributed Session
Summarizing historical information for making go/no go decisions in phase II clinical trials

Session Details

Subodh Selukar
2021 (Virtual) Annual Meeting

Contributed Session
STRATIFIED RANDOMIZATION FOR PLATFORM TRIALS WITH DIFFERING EXPERIMENTAL ARM ELIGIBILITY

Session Details

Sasha Kravets
2021 (Virtual) Annual Meeting

Contributed Session
STATISTICAL CONSIDERATIONS FOR SEQUENTIAL, MULTIPLE ASSIGNMENT, RANDOMIZED TRIALS

Session Details

Leslie Revoredo
2021 (Virtual) Annual Meeting

Contributed Session
Responsible Tracking and Accounting of Participant Mental Health Urgency/Emergency Responses in Substance Use Treatment Clinical Trials

Session Details

Yuanxi Jia
2021 (Virtual) Annual Meeting

Contributed Session
Redundant Clinical Trials Are Hurting Patients An Example of Randomized Clinical Trials Conducted in mainland China Evaluating Statins among Patients with Coronary Artery Disease

Session Details

Kimberly Carlson
2021 (Virtual) Annual Meeting

Contributed Session
PTXRx Study: How Pragmatic Trial Design can Inoculate Against Risks to Study Integrity in a Global Pandemic

Session Details

David Zahrieh
2021 (Virtual) Annual Meeting

Contributed Session
Prediction of participant satisfaction in cancer chemoprevention clinical trials using random forests

Session Details

Alyssa Vanderbeek
2021 (Virtual) Annual Meeting

Contributed Session
Platform trials take the spotlight in COVID-19

Session Details

Tao Wang
2021 (Virtual) Annual Meeting

Contributed Session
PHASE I CAR-T CLINICAL TRIALS REVIEW

Session Details

Christin Hoffmann
2021 (Virtual) Annual Meeting

Contributed Session
A CORE OUTCOME SET FOR STANDARDIZING AND REPORTING SURGICAL INNOVATION: RESULTS OF AN INTERNATIONAL DELPHI SURVEY AND CONSENSUS MEETING

Session Details

Radhika Kondapaka
2021 (Virtual) Annual Meeting

Contributed Session
LEVERAGING PATIENT PROFILES FOR ROUTINE PHARMACOVIGILANCE IN CLINICAL TRIALS

Session Details

Sharone Edelstein
2021 (Virtual) Annual Meeting

Contributed Session
Lessons learned from The Restoring Insulin Secretion (RISE) Study: A multi-protocol, multi-center clinical trial in adults and youth with prediabetes and early type 2 diabetes

Session Details

Danila Azzolina
2021 (Virtual) Annual Meeting

Contributed Session
How informative is informative in small size trials: a simulation study

Session Details

Victoria Homer
2021 (Virtual) Annual Meeting

Contributed Session
GUIDELINES FOR THE CONTENT OF STATISTICAL ANALYSIS PLANS FOR EARLY PHASE CLINICAL TRIALS

Session Details

Liyun Jiang
2021 (Virtual) Annual Meeting

Contributed Session
Elastic Priors to Dynamically Borrow Information from Historical Data in Clinical Trials

Session Details

Kathryn Evans
2021 (Virtual) Annual Meeting

Contributed Session
Discriminant validity of the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS) in adult and pediatric phase II and III clinical trials

Session Details

Kathryn Hefner
2021 (Virtual) Annual Meeting

Contributed Session
Development of a COVID-19 Impact Assessment for National Drug Abuse Treatment (NDAT) Clinical Trials Network (CTN)

Session Details

Marcus Johnson
2021 (Virtual) Annual Meeting

Contributed Session
Development and Implementation of Work Engagement Strategies in a Clinical Research Consortium During the Coronavirus Disease 2019 (COVID-19) Pandemic

Session Details

Siyun Yang
2021 (Virtual) Annual Meeting

Contributed Session
Covariate adjustment in subgroup analyses of randomized clinical trials: A propensity score approach

Session Details

Fei Yuan
2021 (Virtual) Annual Meeting

Contributed Session
Cost-Effectiveness analysis of cardiac versus non-cardiac surgery on cardiovascular-disease population

Session Details

Xiaoyu Tang
2021 (Virtual) Annual Meeting

Contributed Session
Bayesian multivariate network meta-analysis model for the difference in restricted mean survival times

Session Details

Andrea Marraffino
2021 (Virtual) Annual Meeting

Contributed Session
Automated, customized, patient-centric performance feedback in clinical trials to improve data accuracy and patient compliance

Session Details

Shun Fu Lee
2021 (Virtual) Annual Meeting

Contributed Session
Analysis for cluster-randomized crossover trials with multiple periods.

Session Details

Bryan Nelson
2021 (Virtual) Annual Meeting

Contributed Session
An Examination of Methods for Parameter Estimation Following Adaptive Group Sequential Clinical Trials

Session Details

Wen Zhang
2021 (Virtual) Annual Meeting

Contributed Session
A Bayesian group sequential design for randomized biosimilar clinical trials with adaptive information borrowing from historical data

Session Details

Qilu Yu
2021 (Virtual) Annual Meeting

Session Proposal
Managing Pragmatic Clinical Trials in the Time of COVID-19

Session Details

Zachary Hallinan
2021 (Virtual) Annual Meeting

Educational Session
Accelerating evidence generation through quality by design

Session Details

Stefan Englert
2021 (Virtual) Annual Meeting

Educational Session
How the estimand addendum to the ICH E9 guideline helps structure clinical objectives, analyses, and conclusions – a series of oncology case studies

Session Details

Audrey Mauguen
2021 (Virtual) Annual Meeting

Contributed Session
THE TRUE POWER OF CLINICAL TRIALS IN PEDIATRIC CANCERS AND OTHER RARE DISEASES

Session Details

Lauren Balmert
2021 (Virtual) Annual Meeting

Session Proposal
Operational Innovations in Academic Data Analysis and Coordinating Centers

Session Details

Thomas Cook
2021 (Virtual) Annual Meeting

Session Proposal
Missing Data in Clinical Trials: principles, planning, prevention

Session Details

Lehana Thabane
2021 (Virtual) Annual Meeting

Session Proposal
Design and conduct of pilot and feasibility trials: focus on unresolved issues

Session Details

Rema Raman
2021 (Virtual) Annual Meeting

Session Proposal
Impact of the COVID-19 Pandemic on the Design, Operations and Analysis Plans of Dementia Trials

Session Details

The RECOVERY Collaborative Group
2021 (Virtual) Annual Meeting

Trial of the Year Award
RECOVERY - Randomised Evaluation of COVID-19 Therapy

Yves Rosenberg
2021 (Virtual) Annual Meeting

Educational Session
Essentials of Clinical Trials

Session Details

Anna Heath
2021 (Virtual) Annual Meeting

Educational Session
Designing Clinical Research to Inform Decision-Making using Value of Information

Session Details

Susan Halabi, Domenic Reda, Li Chen, Liz Garrett-Mayer, Mithat Gönen, Colin Begg
2021 (Virtual) Annual Meeting

Special Presentation
Annual Business Meeting 2021

J. Jack Lee, 2021 SCT Fellows
2021 (Virtual) Annual Meeting

Fellows Presentation
Presentation of the Class of 2021 Fellows

Pralay Mukhopadhyay
2021 (Virtual) Annual Meeting

Session Proposal
Challenges with COVID-19 Vaccine Development and Assessing Impact of the Pandemic on Oncology Trial Outcomes

Session Details

Darren Courtney
2021 (Virtual) Annual Meeting

Session Proposal
Choices, choices: Selecting, defining, and measuring outcomes for young people with depressive disorders

Session Details

Holly Janes
2021 (Virtual) Annual Meeting

Session Proposal
Current issues in the design and analysis of COVID-19 vaccine efficacy trials

Session Details

Dee Blumberg
2021 (Virtual) Annual Meeting

Session Proposal
Challenges and Best Practices for Recruitment and Retention During the COVID Pandemic

Session Details

James Wason
2021 (Virtual) Annual Meeting

Contributed Session
Costs and Staffing Resource Requirements for Adaptive Trials: results from the Costing Adaptive Trials (CAT) Project

Session Details

Beatriz Goulao
2021 (Virtual) Annual Meeting

Contributed Session
Patient and public involvement in numerical aspects of trials: a theory-informed survey of trialists current practices, barriers and facilitators

Session Details

Yumin Wang
2021 (Virtual) Annual Meeting

Contributed Session
Design and analysis of partially randomized preference trials with propensity score stratification

Session Details

Xinyu Tang
2021 (Virtual) Annual Meeting

Contributed Session
The Use of Conditional Power in Vaccine Trials with Seasonal Variations

Session Details

Laura Levit
2021 (Virtual) Annual Meeting

Session Proposal
It Can Be Done! Equitable, Accessible, and Efficient Clinical Trials Through Streamlined Protocol Designs and Requirements

Session Details

Chen Hu
2021 (Virtual) Annual Meeting

Session Proposal
recent developments in quantitative benefit-risk assessment in clinical trials

Session Details

Tyler Bonnett
2021 (Virtual) Annual Meeting

Session Proposal
Design and Implementation of Clinical Trials in a Pandemic – Reflecting on the ACTT Studies

Session Details

Hayley Belli
2021 (Virtual) Annual Meeting

Contributed Session
Guidelines regarding the enrollment of patients and evidence from Expanded Access programs: A case study of convalescent plasma therapy for the treatment of COVID-19

Session Details

Alice Faust
2021 (Virtual) Annual Meeting

Contributed Session
Challenges and proposed solutions in making clinical research on COVID-19 ethical. A status quo analysis across German research ethics committees

Session Details

Jody Ciolino
2021 (Virtual) Annual Meeting

Contributed Session
Making interim decisions using conditional power based on a surrogate endpoint

Session Details

Arsenio Paez
2021 (Virtual) Annual Meeting

Contributed Session
Intervention fidelity and treatment effect estimates in clinical trials of complex interventions: A meta-epidemiological study.

Session Details

Susan Halabi
2021 (Virtual) Annual Meeting

Session Proposal
SCT New Committees and DMC Training Initiative

Session Details

Monica Taljaard
2021 (Virtual) Annual Meeting

Session Proposal
Pragmatic trials: key unresolved ethical issues and the need for guidance

Session Details

Janel Fedler
2021 (Virtual) Annual Meeting

Session Proposal
The Impact of COVID-19 on the Conduct of Trials in the NeuroNEXT Network

Session Details

Kert Viele
2021 (Virtual) Annual Meeting

Session Proposal
Bayesian Modeling in COVID-19 – Disease Modeling, Therapeutics, and Vaccines

Session Details

Julissa Almonte Santana
2021 (Virtual) Annual Meeting

Contributed Session
Web-Based Lab Tracking for Lab Blood Data Collection and Shipping Manifest Creation

Session Details

Jennifer Le-Rademacher
2021 (Virtual) Annual Meeting

Contributed Session
Adverse Event Burden Score—A Versatile Summary Measure for Cancer Clinical Trials

Session Details

Susan Halabi
2021 (Virtual) Annual Meeting

Contributed Session
On the Design of Stratified Biomaker Trials with Measurement Error

Session Details

Subodh R. Selukar, Siyun Yang, Xiaoyu Tang
2021 (Virtual) Annual Meeting

Award Presentation
Thomas C. Chalmers Scholarship Finalists

Lehana Thabane
2021 (Virtual) Annual Meeting

Session Proposal
INCREASING DIVERSITY IN CARDIOVASCULAR CLINICAL TRIALS: ENGAGEMENT, RECRUITMENT, LEADERSHIP

Session Details

Jonathan Cook
2021 (Virtual) Annual Meeting

Session Proposal
The ASPIRE guidance on surgical placebo controls in randomised trials

Session Details

Erinn Hade
2021 (Virtual) Annual Meeting

Session Proposal
Sample size re-estimation: Reflections on implementation and extensions to complex designs

Session Details

Ashley Wegel
2021 (Virtual) Annual Meeting

Session Proposal
Adaptive COVID-19 Treatment Trial (ACTT) Data Management: Ensuring Success in a Constantly-Evolving, High-Demand Pandemic Environment

Session Details

Sheng Luo
2021 (Virtual) Annual Meeting

Educational Session
Design Clinical Trials with Multiple Endpoints: Methods and Applications

Session Details

Martin Landray
2021 (Virtual) Annual Meeting

Curtis Meinert Lecture
Better Trials for Better Health

Susan Halabi
2021 (Virtual) Annual Meeting

Educational Session
Biomarker Driven Trials for Precision Medicine

Session Details

Jody Ciolino, SCT Membership Committee
2021 (Virtual) Annual Meeting

Special Presentation
New Member Welcome & Orientation

Greg Ball
2021 (Virtual) Annual Meeting

Session Proposal
Different Clinical Trial Analyses for Different Stakeholders

Session Details

Saurabh Mukhopadhyay
2021 (Virtual) Annual Meeting

Session Proposal
Leveraging External Evidence in Clinical Research using Novel Statistical Methods

Session Details

Shahrul Mt-Isa
2021 (Virtual) Annual Meeting

Session Proposal
Benefit-Risk Assessment in Clinical Trials with Individual Patient Needs in Mind

Session Details

James Albert
2021 (Virtual) Annual Meeting

Session Proposal
Design and Implementation of a Vaccine Trial in a Pandemic – mRNA-1273 Phase I Trial

Session Details

Nikki Totton
2021 (Virtual) Annual Meeting

Contributed Session
Utilising Benefit-Risk Assessments within Clinical Trials

Session Details

Sonia Jain
2021 (Virtual) Annual Meeting

Session Proposal
Design, Implementation, and Analysis of N-of-1 Clinical Trials

Session Details

Charles Weijer
2021 (Virtual) Annual Meeting

Session Proposal
Ethics and future of human challenge trials with SARS-CoV-2 to speed vaccine development

Session Details

Cliff Lane
2021 (Virtual) Annual Meeting

Founders Lecture
Conducting Clinical Research in the Setting of an Outbreak: From HIV to Ebola to COVID-19

Dikla Blumberg
2020 (Virtual) Annual Meeting

Session Proposal
Strategies to Collaboratively Manage Protocol Deviations in Multi-Site Clinical Trials

Session Details

Amy Ruppert Stark
2020 (Virtual) Annual Meeting

Session Proposal
The design and implementation of Master Protocols using examples from oncology clinical trials.

Session Details

Simon Bacon
2020 (Virtual) Annual Meeting

Session Proposal
Methodological advances in the conduct of behavioral clinical trials: An International Behavioural Trials Network (IBTN) update.

Session Details

Lu Mao Mao
2020 (Virtual) Annual Meeting

Session Proposal
The win ratio approach to composite endpoints

Session Details

Brooke Erchinger
2020 (Virtual) Annual Meeting

Educational Session
Using meta-analysis to combine results from clinical trials

Session Details

Susan Czajkowski
2020 (Virtual) Annual Meeting

Educational Session
From Ideas to Efficacy: Designing & Optimizing Behavioral Treatments for Chronic Diseases

Session Details

Cody Chiuzan
2020 (Virtual) Annual Meeting

Educational Session
Web-based applications for early-phase trials designs

Session Details

Michael Rosenblum
2020 (Virtual) Annual Meeting

Session Proposal
Adjusting for Prognostic Baseline Variables to Improve Precision and Power in Randomized Trials

Session Details

Elizabeth Wright
2020 (Virtual) Annual Meeting

Session Proposal
Management and Sharing of Individual Participant Deidentified Data (IPD)

Session Details

Andrew Embleton-Thirsk
2020 (Virtual) Annual Meeting

Contributed Session
Contrasting case-studies of non-commercial trials being used as a pivotal evidence in licencing submissions to the European Medicines Agency

Session Details

Meredith Warshaw
2020 (Virtual) Annual Meeting

Contributed Session
IMPAACT 2016: Interdisciplinary Collaboration at Multiple Levels

Session Details

Jason Kojtek
2020 (Virtual) Annual Meeting

Contributed Session
Building a drug management system

Session Details

Susan Halabi, Mithat Gönen
2020 (Virtual) Annual Meeting

Fellows Presentation
Presentation of the Class of 2020 Fellows

Levent Bayman
2020 (Virtual) Annual Meeting

Contributed Session
Real-Time Risk-Based Monitoring in Clinical Trials Using Business Intelligence Tools (Unlikely Companions)

Session Details

Levent Bayman
2020 (Virtual) Annual Meeting

Contributed Session
Transition From Two Phase 3 Clinical Trials To A Reduced Follow-Up Only Trial

Session Details

Deborah Zarin
2020 (Virtual) Annual Meeting

Contributed Session
Addressing Challenges in Registering and Reporting Results for Master Protocol Studies

Session Details

Anna Heath
2020 (Virtual) Annual Meeting

Contributed Session
A Bayesian Continual Reassessment Design for a Dose Ranging Study of Intranasal Dexmedetomidine for Paediatric Laceration Repair

Session Details

Anna Heath
2020 (Virtual) Annual Meeting

Contributed Session
The KidsCAN-PERC Innovative Paediatric Clinical Trials Network (iPCT): An Interdisciplinary Approach to Clinical Trials Methodology.

Session Details

Anna Heath
2020 (Virtual) Annual Meeting

Contributed Session
Determining a Bayesian Predictive Power Stopping Rule for Futility in a Non-Inferiority Trial with Binary Outcomes: The INK trial

Session Details

Chris Rogers
2020 (Virtual) Annual Meeting

Contributed Session
Automation of clinical trial statistical monitoring

Session Details

Danila Azzolina
2020 (Virtual) Annual Meeting

Contributed Session
Bayesian HPD-based sample sizedetermination using semi-parametric prior elicitation

Session Details

Daniele Bottigliengo
2020 (Virtual) Annual Meeting

Contributed Session
Central Statistical Data Quality Monitoring in Clinical Studies: an application to the ROLEX registry

Session Details

Danila Azzolina
2020 (Virtual) Annual Meeting

Contributed Session
Bayesian methods to cope with poor accrual in pediatric trials

Session Details

Kelly Folkers
2020 (Virtual) Annual Meeting

Contributed Session
Data from Expanded Access: Opportunity for Real World Evidence Collection and Insights?

Session Details

Fuad Abujarad
2020 (Virtual) Annual Meeting

Contributed Session
Comparing a Multimedia Interactive Virtual Informed Consent (VIC) to Traditional Paper-based Method: A randomized Clinical Trial

Session Details

Ilaria Domenicano
2020 (Virtual) Annual Meeting

Contributed Session
Determining mental health condition patterns in Veterans with a lifetime PTSD diagnosis

Session Details

Grecio Sandoval
2020 (Virtual) Annual Meeting

Contributed Session
Cost-Efficient Clinical Studies with Continuous Time-to-Event Outcomes

Session Details

Jessica Guyer
2020 (Virtual) Annual Meeting

Contributed Session
Clinical Trial Design, Protocol Implementation, and Secular Treatment Trends for Persons Living with HIV and Opioid Use Disorder: Lessons Learned from a National Institute on Drug Abuse Clinical Trials Network (CTN) Trial

Session Details

Fei Yuan
2020 (Virtual) Annual Meeting

Contributed Session
The Association between Genotypes and Post Cardiac Surgery Bleedings: A substudy of the Steroids in Cardiac Surgery Trial (SIRS)

Session Details

Lucy Culliford
2020 (Virtual) Annual Meeting

Contributed Session
Do study participants complete electronic questionnaires?

Session Details

Shray Alag
2020 (Virtual) Annual Meeting

Contributed Session
Extracting Unique Insights by Mining Single Nucleotide Polymorphisms (SNPs) from ClinicalTrials.gov and Applying the Human Phenotype Ontology

Session Details

Rick Mitchell
2020 (Virtual) Annual Meeting

Contributed Session
Ensuring Consistency Across CDISC Dataset Programming Processes

Session Details

Daniel Kang
2020 (Virtual) Annual Meeting

Contributed Session
Efficient Bayesian Adaptive Design for Oncology Clinical Trials with Multiple Biomarker Subgroups

Session Details

Nora Hutchinson
2020 (Virtual) Annual Meeting

Contributed Session
How Many Patients Does It Take to Develop a New Cancer Drug? A Cohort Study of Pre-license Oncology Drugs

Session Details

Jonathan Walsh
2020 (Virtual) Annual Meeting

Contributed Session
Improving Clinical Trial Efficiency Using Machine Learning Models of Disease Progression

Session Details

Russell Thirard
2020 (Virtual) Annual Meeting

Contributed Session
Integrating expert opinions with clinical trial data to increase power to detect a treatment effect in subgroups: example of a Bayesian analysis of the VeRDiCT trial

Session Details

Chris Rogers
2020 (Virtual) Annual Meeting

Contributed Session
Instrumental variable methods for assessing the causal effect of an intervention in the presence of differential non-adherence; application to the AIRWAYS-2 trial

Session Details

Yuanyuan Lu
2020 (Virtual) Annual Meeting

Contributed Session
How Big is a Big Hazard Ratio in Clinical Trials?

Session Details

Dikla Blumberg
2020 (Virtual) Annual Meeting

Session Proposal
Regulatory considerations for a multi-site clinical trial treating opioid use disorder (OUD) with vulnerable populations: pregnant women, infants, and potential prisoners

Session Details

Yue Song
2020 (Virtual) Annual Meeting

Contributed Session
Random-effects meta-analysis of combined outcomes based on reconstructions of individual patient data

Session Details

Kristina Lindsley
2020 (Virtual) Annual Meeting

Contributed Session
Public availability of clinical trial results from a random sample of systematic reviews

Session Details

Matthew Gooden
2020 (Virtual) Annual Meeting

Contributed Session
The Impact of Site Initiation Visits on Non Compliance in Neurology Research

Session Details

Alicia Williams
2020 (Virtual) Annual Meeting

Contributed Session
The Impact of Different Missing Data Imputation Methods: a case study using the Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) Study

Session Details

Alisa Stephens-Shields
2020 (Virtual) Annual Meeting

Contributed Session
Simulation-based Design of Pragmatic Trials in Psoriatic Arthritis Using Propensity Scores

Session Details

Rouba Chahine
2020 (Virtual) Annual Meeting

Contributed Session
Sample Size Methods for Two-Stage Randomized Trials with Time to Event Data

Session Details

Isabelle Weir
2020 (Virtual) Annual Meeting

Contributed Session
Counterfactual mediation analysis with multistate models for surrogate and clinical time-to-event outcomes

Session Details

Victoria Trapani
2020 (Virtual) Annual Meeting

Contributed Session
Vital Status Ascertainment in a Long-Term Clinical Study of Type 1 Diabetes

Session Details

Wendi Liang
2020 (Virtual) Annual Meeting

Contributed Session
Using Results from a Natural History Study to Reduce Patient Burden in Later Clinical Trials

Session Details

Phoebe Gauthier
2020 (Virtual) Annual Meeting

Contributed Session
Using an Interdisciplinary Approach to Develop a Medical Record Abstraction and Quality Assurance Process for Generating the Primary Outcome in a Multi-Site Implementation Study

Session Details

Deborah Profit, PhD
2020 (Virtual) Annual Meeting

Contributed Session
The Value Proposition of eConsent in Clinical Trials

Session Details

Catherine Houghton
2020 (Virtual) Annual Meeting

Contributed Session
Potential participants’ views on the factors that impact on their decision to take part in a randomised trial: A qualitative evidence synthesis.

Session Details

Patricia Vanderwolf
2020 (Virtual) Annual Meeting

Contributed Session
Patient-Focused Research on Metachromatic Leukodystrophy

Session Details

Richard Hooper
2020 (Virtual) Annual Meeting

Contributed Session
Optimal incomplete designs for stepped wedge trials in continuous time

Session Details

Anna Heath
2020 (Virtual) Annual Meeting

Contributed Session
Adaptive Seamless Phase II/III Design for the Ketodex trial

Session Details

Jiyu Kim
2020 (Virtual) Annual Meeting

Contributed Session
Analysis of multicenter clinical trials with very low event rates

Session Details

ASM Borhan
2020 (Virtual) Annual Meeting

Contributed Session
Analysis and reporting of data from stratified cluster randomized trials – a systematic survey

Session Details

Emily Hite
2020 (Virtual) Annual Meeting

Contributed Session
An examination of treatment interventions for glioblastoma multiforme and its affect on patient withdrawals/drop outs

Session Details

Guilherme Lopes
2020 (Virtual) Annual Meeting

Contributed Session
A novel method of reporting adverse effects in cancer clinical trials.

Session Details

Student finalists presenting their papers and the winner announced live during the webinar!
2020 (Virtual) Annual Meeting

Award Presentation
Thomas C. Chalmers Student Scholarship

Jean-Jacques Muyembe-Tamfum, Lori Dodd, Oliver Tshiani Mbala, and Jamila Adoulhab
2020 (Virtual) Annual Meeting

Trial of the Year Award
Pamoja Tulinde Maisha (PALM ["Together Save Lives"] in the Kiswahili language) trial

SCT President, Officers and Committee Chairs
2020 (Virtual) Annual Meeting

Special Presentation
Annual Business Meeting 2020

Chengwu Yang
2020 (Virtual) Annual Meeting

Award Presentation
Sylvan Green Award

Michael Grayling
2020 (Virtual) Annual Meeting

Contributed Session
Where is the good? The bad and the ugly of single-arm trial reporting

Session Details

Penny Reynolds
2020 (Virtual) Annual Meeting

Contributed Session
Where have all the trials gone? Academic trialists do not report clinical trial results

Session Details

James Moore
2020 (Virtual) Annual Meeting

Contributed Session
Wearable Devices: Technology, Time Issues and Statistical Resolutions

Session Details

Quyen Duong
2020 (Virtual) Annual Meeting

Contributed Session
Understanding Verbosity: Associations between Consent Form Length and Funding Source in Cancer Clinical Trials

Session Details

Kari Williams
2020 (Virtual) Annual Meeting

Contributed Session
The Impact of Interdisciplinary Relationships on Single IRB Selection in a National Clinical Trial Network

Session Details

Arsenio Paez
2020 (Virtual) Annual Meeting

Contributed Session
The IDEAL Reporting Guidelines for Reporting the Evaluation of Surgical Innovation

Session Details

Arsenio Paez
2020 (Virtual) Annual Meeting

Contributed Session
The CONSIDER framework - Guiding intervention fidelity and study design in clinical trials of surgery.

Session Details

Kathryn Arnold
2020 (Virtual) Annual Meeting

Contributed Session
Successful implementation of a novel trial design in a palliative care population

Session Details

Xiaoyan Yin
2020 (Virtual) Annual Meeting

Contributed Session
Sequential, Multiple-Assignment, Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART-COMPASS): Design Considerations for Selecting the Optimal Treatment

Session Details

Janel Fedler
2020 (Virtual) Annual Meeting

Contributed Session
Sample Size Estimates for Optical Coherence Tomography Outcome Measures Based on Trends Observed in the SPRINT-MS Trial

Session Details

Kevin Fain
2020 (Virtual) Annual Meeting

Contributed Session
Race and ethnicity reporting for clinical trials in ClinicalTrials.gov and publications.

Session Details

Muniza Sheikh
2020 (Virtual) Annual Meeting

Contributed Session
National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element (CDE) Recommendations: Project Overview and Recent Updates

Session Details

Michael Grayling
2020 (Virtual) Annual Meeting

Contributed Session
Multi-arm multi-stage designs with fixed stage-wise sample sizes

Session Details

Lawrence Ragard
2020 (Virtual) Annual Meeting

Contributed Session
Interdisciplinary collaboration in review of national coverage analysis (NCA) documents to enhance clinical trial site activation and recruitment of participants.

Session Details

Elias Klemperer
2020 (Virtual) Annual Meeting

Contributed Session
Implementation, recruitment, and retention for an emergency department initiated buprenorphine intervention for opioid use disorder

Session Details

Elizabeth Wright
2020 (Virtual) Annual Meeting

Contributed Session
Data Sharing Plans in Manuscripts Reporting Results of Randomized Clinical Trials Published in International Committee of Medical Journal Editors Member Journals during 2019

Session Details

Joseph Rausch
2020 (Virtual) Annual Meeting

Contributed Session
Comparing ANCOVA and Constrained Longitudinal Data Analysis for Examining Moderators in Randomized Clinical Trials

Session Details

Brian Burke
2020 (Virtual) Annual Meeting

Contributed Session
Closing Out a Long-Term Longitudinal Study: Lessons from the TODAY Study

Session Details

Chenxiang Li
2020 (Virtual) Annual Meeting

Contributed Session
Generalization of Randomized Trial Results with Latent Motivation – A Propensity Score Approach

Session Details

Lan Zhang
2020 (Virtual) Annual Meeting

Contributed Session
Buy or Build: Considerations for a robust data management system used in Phase 3 Clinical Studies

Session Details

James Wise
2020 (Virtual) Annual Meeting

Contributed Session
Building a Comprehensive Clinical Site Performance Portal in Support of Risk-Based Monitoring

Session Details

Christina Clise
2020 (Virtual) Annual Meeting

Contributed Session
Blurring the Boundaries Between Clinical Trials and Healthcare Ecosystems.

Session Details

Joel Gagnier
2020 (Virtual) Annual Meeting

Contributed Session
Bias Associated with Patient Reported Outcome Measures in Meta-Analyses

Session Details

Arsenio Paez
2020 (Virtual) Annual Meeting

Contributed Session
Beyond the RCT: When are randomised trials unnecessary for new therapeutic devices, and what should we do instead?

Session Details

Carlton Hornung
2020 (Virtual) Annual Meeting

Contributed Session
Assessing the Competency of the Clinical Research Workforce: Formal Education; Role in the Research Enterprise; Research Setting; and Years of Experience.

Session Details

Tolulope Abidogun
2020 (Virtual) Annual Meeting

Contributed Session
Analysis of Intent to Share Individual Participant Data (IPD) for Clinical Trials Registered on ClinicalTrials.gov

Session Details

Arsenio Paez
2020 (Virtual) Annual Meeting

Contributed Session
An introduction to ideal

Session Details

Caroline Kristunas
2020 (Virtual) Annual Meeting

Contributed Session
An evaluation of the use of covariate constrained randomisation for stepped-wedge cluster randomised trial

Session Details

Gary Gensler
2020 (Virtual) Annual Meeting

Contributed Session
Addressing changes to a closeout data set

Session Details

Janet Athene Lane
2020 (Virtual) Annual Meeting

Contributed Session
A digital story of strategies for surgical trainees working together to achieve success in conducting surgical clinical trials

Session Details

Graham Wheeler
2020 (Virtual) Annual Meeting

Educational Session
How to design and run an adaptive clinical trial: new resources and easy-to-use software

Session Details

James Wagner
2020 (Virtual) Annual Meeting

Educational Session
Improving Quality and Controlling Costs in Clinical Trials Using Responsive Survey Design

Session Details

Various Speakers
2019 (New Orleans) Annual Meeting

Special Presentation
Special Founders Session

James J. Dignam & Letitia Perdue
2019 (New Orleans) Annual Meeting

Award Presentation
Thomas C. Chalmers Scholarship, Sylvan Green & Poster Awards

Dr. Monica Bertagnolli
2019 (New Orleans) Annual Meeting

Founders Lecture
Building a learning health care system, and learning from every patient

Susan Halabi
2019 (New Orleans) Annual Meeting

Fellows Presentation
Presentation of the Class of 2019 Fellows

Dr. Lynette Keyes-Elstein
2019 (New Orleans) Annual Meeting

Trial of the Year Award
The Scleroderma: Cyclophosphamide or Transplantation (SCOT) trial

Sumithra Mandrekar
2019 (New Orleans) Annual Meeting

Presidential Welcome
Clinical Trials: A Catalyst for Societal Advancement through Innovation

Thomas Fleming
2019 (New Orleans) Annual Meeting

Curtis Meinert Lecture
Striving to achieve and protect the integrity of clinical trials

Li Chen
2019 (New Orleans) Annual Meeting

Session Proposal
Synthesize Read-World Data with Randomized Clinical Trial Data for Efficient Drug Development

Session Details

Joel Stevans
2019 (New Orleans) Annual Meeting

Contributed Session
Implementation of the Multi-Site Pragmatic Cluster Randomized Controlled Trial: Targeted Interventions to Prevent Chronic Low Back Pain (LBP) in High Risk Patients (TARGET)

Session Details

Charity Patterson
2019 (New Orleans) Annual Meeting

Contributed Session
MULTIPLE, INNOVATIVE, REDCAP PROJECTS FOR TWO SIMULTANEOUS MULTICENTER TRIALS.

Session Details

Rebecca Neiberg
2019 (New Orleans) Annual Meeting

Contributed Session
ASSESSING DATA QUALITY OF PARTICIPANT WEIGHTS UPLOADED FROM SMART SCALES: THE STUDY OF NOVEL APPROACHES TO PREVENTION CLINICAL TRIAL – EXTENSION PHASE

Session Details

Kelley Kidwell
2019 (New Orleans) Annual Meeting

Educational Session
SMART clinical trial design for large and small samples

Session Details

Shaun Treweek
2019 (New Orleans) Annual Meeting

Contributed Session
Increasing the trial process evidence base without increasing research waste

Session Details

David Kent
2019 (New Orleans) Annual Meeting

Educational Session
Personalized evidence based medicine: predictive approaches to heterogeneous treatment effects in randomized trials

Session Details

Juliana Tolles
2019 (New Orleans) Annual Meeting

Session Proposal
Challenges and Best Practices for Data Monitoring Committees (DMCs) Overseeing Adaptive Clinical Trials

Session Details

Jessica Kasza
2019 (New Orleans) Annual Meeting

Contributed Session
Staircase cluster randomised trial designs

Session Details

Katie Jentoft
2019 (New Orleans) Annual Meeting

Contributed Session
CONVERTING VALIDATED SCALES INTO CONSOLIDATED ELECTRONIC CASE REPORT FORMS

Session Details

Shun Fu Lee
2019 (New Orleans) Annual Meeting

Contributed Session
Sample size calculation for cluster randomized crossover trials of multiple periods.

Session Details

Kerry Avery
2019 (New Orleans) Annual Meeting

Contributed Session
A modular core outcome set for seamless, standardised evaluation and reporting of outcomes throughout the surgical device innovation lifecycle: the COHESIVE study

Session Details

Kerry Avery
2019 (New Orleans) Annual Meeting

Contributed Session
Developing a hospital-integrated system for electronic patient-reporting, detection and management of symptoms and complications after surgery

Session Details

Various Speakers
2019 (New Orleans) Annual Meeting

Special Presentation
Annual Business Meeting 2019

Gareth Davies
2019 (New Orleans) Annual Meeting

Contributed Session
Surgeons’ lack of understanding of levels of evidence and trial methodology is a major barrier to randomized trials in surgery

Session Details

Naveen Pereira
2019 (New Orleans) Annual Meeting

Contributed Session
TAILOR PCI: Transitioning a Genotype Based Randomized Clinical Trial to a Registry Using Digital Solutions

Session Details

Lisa Bailey
2019 (New Orleans) Annual Meeting

Contributed Session
'Don't Cut it Out': The Importance of Quality Control in Surgical Trials

Session Details

Kate Harvey
2019 (New Orleans) Annual Meeting

Contributed Session
‘Exploring the feasibility of using mixed methods within an IDEAL 2a/2b study to facilitate the safe, transparent and efficient early-phase evaluation of a novel surgical technique: The Pre-BRA study.’

Session Details

Kerenza Hood
2019 (New Orleans) Annual Meeting

Contributed Session
‘First do no harm’ – exploring the potential impact of placebo treatments on adverse effects

Session Details

Shaunagh Browning
2019 (New Orleans) Annual Meeting

Session Proposal
“The Clinical Research Nurse in Clinical Trials: Value Added?” A Panel Discussion on the Nurses' Role on the Clinical Trials Team

Session Details

Thomas Tollefsen
2019 (New Orleans) Annual Meeting

Contributed Session
“What matters to you?” Preliminary results from a randomized controlled effectiveness trial

Session Details

Kandi Velarde
2019 (New Orleans) Annual Meeting

Contributed Session
A Bold Collaboration Between the Recruitment Innovation Center (RIC) and the Department of Veterans Affairs (VA) to Develop a Case-Based Framework for Sharing Algorithmic Approaches to Facilitate Clinical Research Planning and Recruitment

Session Details

Ayoola Ademola
2019 (New Orleans) Annual Meeting

Contributed Session
A Comparison of Frequentist and Bayesian Power Analyses for Non-Inferiority Trials Designs

Session Details

Gillian Gresham
2019 (New Orleans) Annual Meeting

Contributed Session
A Comparison of Industry and NIH-funded Clinical Trials Registered in ClinicalTrials.gov

Session Details

Tolu Sajobi
2019 (New Orleans) Annual Meeting

Contributed Session
A Differential Item Functioning Analysis of the DASH Outcome Measure in a Randomized Controlled Trial of Patients with Elbow Fractures

Session Details

Andrew Chapple
2019 (New Orleans) Annual Meeting

Contributed Session
A Hybrid Phase I-II/III Clinical Trial Design Allowing Dose Re-Optimization in Phase III

Session Details

Tolulope Sajobi
2019 (New Orleans) Annual Meeting

Contributed Session
A Literature Review of Baseline Covariate Adjustment Methods in Randomized Clinical Trials

Session Details

Martin Law
2019 (New Orleans) Annual Meeting

Contributed Session
A new class of optimally curtailed trials for phase II oncology trials.

Session Details

Brittney Bailey
2019 (New Orleans) Annual Meeting

Contributed Session
A new predictive mean matching imputation method for data from cluster randomized trials

Session Details

RANI JAYSWAL
2019 (New Orleans) Annual Meeting

Contributed Session
A novel method for PFS ratio endpoint in a Phase II genomic-driven clinical trial

Session Details

Karen Beck
2019 (New Orleans) Annual Meeting

Contributed Session
A Pilot Study to Assess Feasibility and Acceptability of At-Home Self-Collection Sampling for Urine and Saliva

Session Details

Chaoqun Mei
2019 (New Orleans) Annual Meeting

Contributed Session
A Procedure for Comparison of Matched Pairs by Ranking Method

Session Details

Hongli Li
2019 (New Orleans) Annual Meeting

Contributed Session
A Programmatic Approach to the Increased Data Monitoring in the Cooperative Group System Required for FDA Registration Trials

Session Details

Lisa Henn
2019 (New Orleans) Annual Meeting

Contributed Session
A Randomized Controlled Trial with right-skewed dual endpoints in the presence of an unproven but incumbent competing intervention: Rationale and design

Session Details

Michael Grayling
2019 (New Orleans) Annual Meeting

Contributed Session
A review of software availability for adaptive clinical trials

Session Details

J Athene Lane
2019 (New Orleans) Annual Meeting

Contributed Session
A systematic literature review of site staff training methods in clinical trials

Session Details

Thevaa Chandereng
2019 (New Orleans) Annual Meeting

Contributed Session
A Tool for Design and Analysis of Adaptive Bayesian Clinical Trials

Session Details

Chin-Fu Hsiao
2019 (New Orleans) Annual Meeting

Contributed Session
A two-stage selection designs for basket clinical trials

Session Details

Zhenning Yu
2019 (New Orleans) Annual Meeting

Contributed Session
A Unified Approach for Frequentist and Bayesian Hypothesis Testing in Two-Arm Clinical Trials with Binary Outcomes

Session Details

Toshimitsu Hamasaki
2019 (New Orleans) Annual Meeting

Contributed Session
A use of adaptive design in clinical trial for evaluating safety and efficacy of the extracorporeal continuous-flow ventricular assist device in patients with severe heart failure or refractory cardiogenic shock

Session Details

Julia Robertson
2019 (New Orleans) Annual Meeting

Contributed Session
A Web-Based Approach for Tracking and Management of Sleep Device Mailings for In-Home Sleep Assessments in the WHISPER Study

Session Details

Katherine Snapinn
2019 (New Orleans) Annual Meeting

Contributed Session
Achieving balance between standardization and customization with the Statisticians’ Report Worksheet

Session Details

Donna Levy
2019 (New Orleans) Annual Meeting

Contributed Session
Adaptive Designs - Introduction for Non-statisticians - What are they? How do they impact me? What do I need to know?

Session Details

Yannan Jiang
2019 (New Orleans) Annual Meeting

Contributed Session
All New Zealand Acute Coronary Syndrome - Quality Improvement (ANZACS-QI) Programme: Using Routinely Collected National Patient Database for Clinical Trials

Session Details

Kevin Fain
2019 (New Orleans) Annual Meeting

Contributed Session
All-cause mortality reporting in ClinicalTrials.gov compared to publications.

Session Details

Fang-Shu Ou
2019 (New Orleans) Annual Meeting

Contributed Session
Alternative test statistics and their power under non-proportional hazard assumptions

Session Details

Hayley Belli
2019 (New Orleans) Annual Meeting

Contributed Session
An algorithmic approach for determining individualized stage duration in a Sequential Multiple Assignment Randomized Trial (SMART)

Session Details

Jacqueline Chen
2019 (New Orleans) Annual Meeting

Contributed Session
Analysis of Drug Labeling for Information Specific to Geriatric Populations

Session Details

Cindy Cooper
2019 (New Orleans) Annual Meeting

Contributed Session
Anticipated and observed effect sizes in publicly funded randomised controlled trials

Session Details

Jeffery Oliver
2019 (New Orleans) Annual Meeting

Contributed Session
APPLICATION OF KEY RISK INDICATORS TO IMPROVE DATA QUALITY: A NUTRITION COMPANY’S PERSPECTIVE

Session Details

Rene Peralta
2019 (New Orleans) Annual Meeting

Contributed Session
Application of the NIST Randomness Beacon to randomized trials.

Session Details

Jeannette Lee
2019 (New Orleans) Annual Meeting

Contributed Session
Assessing Clinical Trial Self-Perceived Competence Among International Sites Participating in the AIDS Malignancy Consortium

Session Details

Virginia Shipes
2019 (New Orleans) Annual Meeting

Contributed Session
Assessing the Robustness of Interim Stopping Criteria Methods in Phase III Survival Clinical Trials

Session Details

Lindsey Cameron-Dermann
2019 (New Orleans) Annual Meeting

Contributed Session
Association between estrogen and prevalent health-related quality of life in postmenopausal women randomized to the MAP.3 chemoprevention trial

Session Details

Shirley Ge
2019 (New Orleans) Annual Meeting

Contributed Session
Automated Assignment of Congenital Heart Surgery Procedure Types for Accurate Prediction of ICU Length-of-Stay

Session Details

Wenle Zhao
2019 (New Orleans) Annual Meeting

Contributed Session
Automated Site-Subject Payment Management System for Multi-center Clinical Trials

Session Details

Amanda MacPherson
2019 (New Orleans) Annual Meeting

Contributed Session
Benefit and burden in trials of novel, disease-modifying interventions in neurodegenerative disease: A systematic review and meta-analysis

Session Details

Derk Arts
2019 (New Orleans) Annual Meeting

Contributed Session
Benefits of dynamic consent in research - now and tomorrow

Session Details

Lehana THABANE
2019 (New Orleans) Annual Meeting

Educational Session
Beyond the CONSORT extension for pilot trials: guideline, planning, abstracts and protocols

Session Details

Joel Gagnier
2019 (New Orleans) Annual Meeting

Contributed Session
Bias Associated With Patient Reported Outcome Measures in Clinical Trials

Session Details

Lifeng Lin
2019 (New Orleans) Annual Meeting

Contributed Session
Borrowing of strength from indirect evidence in network meta-analyses

Session Details

Zarah Monfaredi
2019 (New Orleans) Annual Meeting

Contributed Session
Building the infrastructure to support patient engagement in clinical trials within an academic hospital

Session Details

Yumi Wakabayashi
2019 (New Orleans) Annual Meeting

Contributed Session
Categorization of Medical Information Databases

Session Details

Pralay Mukhopadhyay
2019 (New Orleans) Annual Meeting

Session Proposal
Challenges in Design, Analysis and Selection of Endpoints in Immuno-Oncology Trials

Session Details

Susanna Barber
2019 (New Orleans) Annual Meeting

Contributed Session
Challenges to Preventing Pregnancy During Ebola Vaccine Clinical Trials in Liberia

Session Details

Matthew Parkes
2019 (New Orleans) Annual Meeting

Contributed Session
Change in Pain and Physical Activity in the InRespond Trial: Can Composite Outcomes Improve Responsiveness?

Session Details

Jianrong Zhang
2019 (New Orleans) Annual Meeting

Contributed Session
Clinical Benefits on Progression-free Survival between Blinded Independent Central Review and Local Assessment in Phase III Randomized Controlled Trials on Solid Tumors: An Analysis of the Results from a Systematic Review

Session Details

SUSAN Ellenberg
2019 (New Orleans) Annual Meeting

Educational Session
Clinical Trial Data Monitoring Committees and Reporting Statistical Centers: The Basics and Emerging Issues

Session Details

Cole Wayant
2019 (New Orleans) Annual Meeting

Contributed Session
Clinical trial endpoints in oncology drug advertisements: a potential mechanism for hype?

Session Details

Mary Redman
2019 (New Orleans) Annual Meeting

Session Proposal
Clinical Trialists Can Help Make Real-World Data Analysis Better

Session Details

Andrew Pilecki
2019 (New Orleans) Annual Meeting

Contributed Session
Clinical trials and healthcare professionals: An analysis of primary factors driving referral behaviors

Session Details

Colin Begg
2019 (New Orleans) Annual Meeting

Session Proposal
Clinical Trials: Meet the Editors

Session Details

Denise Esserman
2019 (New Orleans) Annual Meeting

Session Proposal
Clinical, Practical and Methodological Considerations for Patient Preference Clinical Trials Designs

Session Details

Larisa Tereshchenko
2019 (New Orleans) Annual Meeting

Session Proposal
Clinician-reported outcomes: can we do better?

Session Details

Sarah Gaussoin
2019 (New Orleans) Annual Meeting

Contributed Session
COcoa Supplement and Multivitamin Outcomes Study of Cognitive Function (COSMOS-Mind): Design of a Large Randomized Clinical Trial

Session Details

Matthew` Schipper
2019 (New Orleans) Annual Meeting

Contributed Session
Comparing treatments effect estimates in oncology using randomized clinical trials and observational registries

Session Details

Adelaide Doussau
2019 (New Orleans) Annual Meeting

Contributed Session
Comparison Between Protocols and Publications for Prognostic and Predictive Cancer Biomarker Studies

Session Details

Rebecca Lewis
2019 (New Orleans) Annual Meeting

Contributed Session
Considerations in implementing an electronic patient reported outcomes (ePRO) system

Session Details

Julia Collins
2019 (New Orleans) Annual Meeting

Contributed Session
Considerations in Selection of a Single IRB of Record for Multi-Site Trials

Session Details

Meaghan Adkisson
2019 (New Orleans) Annual Meeting

Contributed Session
Consistent Data Collection Across Multiple Countries

Session Details

Peter Kaufmann
2019 (New Orleans) Annual Meeting

Educational Session
Control Groups, Clinically Important Differences and Effect Sizes in Complex Interventions

Session Details

Jennifer Talton
2019 (New Orleans) Annual Meeting

Contributed Session
Creating Dynamic SAS Reports Across Multiple REDCap Projects

Session Details

Gillian Lancaster
2019 (New Orleans) Annual Meeting

Contributed Session
Creation of the WHO indicators of Infant and Young Child Development (IYCD) as an outcome measure for assessing pre-primary interventions in low and middle income countries: meta data synthesis and field testing methodology

Session Details

Diane Hartford
2019 (New Orleans) Annual Meeting

Contributed Session
Crowdsourcing Solutions for RCT Study Start-Up Pain Points

Session Details

Jack White
2019 (New Orleans) Annual Meeting

Contributed Session
Data Integration in a Multi-site Intervention Through Use of Application Programming Interfaces (APIs)

Session Details

Andrew Rygiel
2019 (New Orleans) Annual Meeting

Contributed Session
DEFINING EVALUABILITY IN A PHASE II, PROSPECTIVE, NON-RANDOMIZED, PRAGMATIC CANCER CLINICAL TRIAL

Session Details

Andrea Anderson
2019 (New Orleans) Annual Meeting

Contributed Session
Designing an Adherence Tracking System for an International Trial

Session Details

Nolan Wages
2019 (New Orleans) Annual Meeting

Educational Session
Designs for modern phase I oncology trials

Session Details

Julie Croft
2019 (New Orleans) Annual Meeting

Contributed Session
Development of a resource to guide set-up and conduct of international surgical clinical trials

Session Details

Manqi Cai
2019 (New Orleans) Annual Meeting

Contributed Session
Development of Methods to handle medication non-adherence in Early Phase Dose-Finding

Session Details

Brett Thombs
2019 (New Orleans) Annual Meeting

Session Proposal
Development of reporting guidelines for randomized controlled trials using cohorts and routinely collected health data

Session Details

Rhiannon Macefield
2019 (New Orleans) Annual Meeting

Contributed Session
Digital images of surgical wounds taken by patient themselves after leaving hospital: exploring the feasibility of a method for remote and blinded outcome assessment of surgical site infection.

Session Details

Hayat Ahmed
2019 (New Orleans) Annual Meeting

Session Proposal
Diverse Representation in Clinical Trials

Session Details

Yuanxi Jia
2019 (New Orleans) Annual Meeting

Contributed Session
Duplicate Patterns and Duplicate Publication Bias among Chinese-sponsored Drug-related Randomized Controlled Trials

Session Details

Jeremy Wolff
2019 (New Orleans) Annual Meeting

Contributed Session
Electronic Healthcare Record Extraction, Transfer, and Use in Clinical Trials: Lessons Learned

Session Details

Cory Goldstein
2019 (New Orleans) Annual Meeting

Contributed Session
Emergency research without consent: an ethical analysis of the ketamine versus haloperidol trial

Session Details

Jianrong Zhang
2019 (New Orleans) Annual Meeting

Contributed Session
Endpoint Surrogacy in Oncological Randomized Controlled Trials with Immunotherapies: A Systematic Review of Meta-analyses

Session Details

yves rosenberg
2019 (New Orleans) Annual Meeting

Educational Session
Essentials of Clinical Trials

Session Details

Lori Dodd
2019 (New Orleans) Annual Meeting

Contributed Session
Establishment of Good Clinical Data Management Practices for a Randomized Clinical Trial during an Ebola Outbreak

Session Details

Victoria Shepherd
2019 (New Orleans) Annual Meeting

Contributed Session
Ethical aspects of surrogate decision-making for clinical trials: a systematic review of empirical research

Session Details

Madeleine Organ
2019 (New Orleans) Annual Meeting

Contributed Session
Evaluating performance of covariate-constrained randomization (CCR) techniques under misspecification of cluster-level variables

Session Details

Elizabeth Ryan
2019 (New Orleans) Annual Meeting

Contributed Session
Evaluation of Bayesian adaptive designs for Phase III trials

Session Details

Anne Welhaven
2019 (New Orleans) Annual Meeting

Contributed Session
Evaluation of Continual Reassessment Method with Lagged Cohort

Session Details

Khalif Halani
2019 (New Orleans) Annual Meeting

Contributed Session
Evaluation of new methods for valid inference in the presence of selection bias

Session Details

Elizabeth Louise Turner Turner
2019 (New Orleans) Annual Meeting

Contributed Session
Evaluation of weighting and imputation methods to deal with missing outcomes in cluster randomized trials

Session Details

Kehao Zhu
2019 (New Orleans) Annual Meeting

Contributed Session
Evolving Practices of Results Reporting in ClinicalTrials.gov

Session Details

Tracy Wolbach
2019 (New Orleans) Annual Meeting

Contributed Session
Expediting New HIV Therapy to the Market through Collaboration with a Contract Research Organization

Session Details

Samiha Islam
2019 (New Orleans) Annual Meeting

Contributed Session
Experience in Implementing a Genomic Test Screening Tool as a Patient Identification Aid in a Precision Medicine Oncology Study

Session Details

Paula Darby Lipman
2019 (New Orleans) Annual Meeting

Contributed Session
EXPLORING CHALLENGES ASSOCIATED WITH EARLY IMPLEMENTATION OF LOW-COST PRAGMATIC TRIALS

Session Details

Jenny Donovan
2019 (New Orleans) Annual Meeting

Contributed Session
Exploring the translation of the UK QRI (QuinteT Recruitment Intervention) to improve and optimise recruitment to clinical trials in the US

Session Details

Phyllis Goodman
2019 (New Orleans) Annual Meeting

Contributed Session
Extending Randomized Clinical Trial Results through Database Linkages

Session Details

KyungMann Kim
2019 (New Orleans) Annual Meeting

Session Proposal
Founders of the Society for Clinical Trials, Inc.

Session Details

Claire Cochran
2019 (New Orleans) Annual Meeting

Session Proposal
From Grant to GANNT, the challenges of setting up a trial in 2018 – lessons learnt for the international stage

Session Details

Matthew Parkes
2019 (New Orleans) Annual Meeting

Contributed Session
Futility of the Treatment, Rather than Futility of the Trial, as the Primary Focus of Interim Analyses in Clinical Trials

Session Details

Bert Arevalo
2019 (New Orleans) Annual Meeting

Contributed Session
GCP Compliance Challenges in Complementary and Alternative Medicine Trials

Session Details

Geng Li
2019 (New Orleans) Annual Meeting

Contributed Session
Graphical Displays of Patient-Reported Outcomes in Interim Clinical Trial Data Monitoring Committee Reports

Session Details

Michael Grayling
2019 (New Orleans) Annual Meeting

Contributed Session
Historical and contemporary opinions on the design of phase II oncology trials

Session Details

Katie Gillies
2019 (New Orleans) Annual Meeting

Session Proposal
How can behavioural science help us design better trials?

Session Details

Loïc Lebellec
2019 (New Orleans) Annual Meeting

Contributed Session
How to quantify the treatment effect in oncology randomized clinical trials with interval-censored data? Restricted Mean Survival Time Difference versus Hazard Ratio and point estimates: results from a simulation study.

Session Details

Logan Sirline
2019 (New Orleans) Annual Meeting

Contributed Session
Implementation of an Innovative Lab Kit and Bio-Sample Specimen Tracking Module within a Clinical Trial Management System

Session Details

Victoria Trapani
2019 (New Orleans) Annual Meeting

Contributed Session
Implementation of Brain Imaging in the Epidemiology of Diabetes Interventions and Complications Study

Session Details

Chris Cook
2019 (New Orleans) Annual Meeting

Contributed Session
Improving Online Tools for Clinical Trial Design

Session Details

Marie Kay
2019 (New Orleans) Annual Meeting

Contributed Session
Improving Risk, Safety, and Data Integrity Oversight through Standardized Protocol Deviation Management – A Data Coordinating Center’s Approach

Session Details

Lawrence Ragard
2019 (New Orleans) Annual Meeting

Contributed Session
IMPROVING TRANSPARENCY IN CLINICAL TRIAL COSTS FOR PARTICIPANTS: NATIONAL CANCER INSTITUTE (NCI) NATIONAL COVERAGE ANALYSIS INITIATIVE SUPPORTED BY THE NCI’S CANCER TRIALS SUPPORT UNIT

Session Details

Jessica Tran
2019 (New Orleans) Annual Meeting

Contributed Session
Inclusion of Limited English Proficient Individuals in Clinical Research

Session Details

Marcus Johnson
2019 (New Orleans) Annual Meeting

Contributed Session
Increasing Access to Clinical Research Using an Innovative Mobile Recruitment Approach: The (MoRe) Concept

Session Details

Nancy Dianis
2019 (New Orleans) Annual Meeting

Contributed Session
Incremental implementation of risk-based monitoring in a resource-constrained environment

Session Details

Kimberley Goldsmith
2019 (New Orleans) Annual Meeting

Contributed Session
Independent treatment mechanisms of cognitive behavioural treatments for Irritable Bowel Syndrome

Session Details

Mary Pautler
2019 (New Orleans) Annual Meeting

Contributed Session
Information Sharing through an Interactive Process Map

Session Details

Lauren Bradley
2019 (New Orleans) Annual Meeting

Contributed Session
Innovative Application of the Jira Software Technology in the Clinical Trial Case Report Form Development Process

Session Details

Gareth Griffiths
2019 (New Orleans) Annual Meeting

Contributed Session
Innovative digital recruitment and retention tools for more efficient conduct of randomised trials

Session Details

Chenguang Wang
2019 (New Orleans) Annual Meeting

Session Proposal
Innovative Early Phase Clinical Trial Designs for Cancer Immunotherapy

Session Details

RANI JAYSWAL
2019 (New Orleans) Annual Meeting

Contributed Session
Interim Monitoring Reports and SAS Macros to Facilitate Reporting and Implementation of Early Phase Clinical Trials

Session Details

Scott Rushing
2019 (New Orleans) Annual Meeting

Contributed Session
Intervention Adherence Tracking Through Use of an Electronic Participant Engagement Platform

Session Details

sally Jo zuspan
2019 (New Orleans) Annual Meeting

Session Proposal
Introduction to Quality by Design and Risk Management: Can you get your staff and study teams to bite?

Session Details

Katie Gillies
2019 (New Orleans) Annual Meeting

Contributed Session
Investigating Clinical Trial Consultations for Discussions of Retention: A Mixed Methods Study

Session Details

Jessica Overbey
2019 (New Orleans) Annual Meeting

Contributed Session
IS CORRECTING FOR MULTIPLE TESTING NECESSARY IN A PLATFORM TRIAL?

Session Details

Katie Minichiello
2019 (New Orleans) Annual Meeting

Contributed Session
Is Pre-Screening a Good Option for Master Protocols? The Lung-MAP Story

Session Details

Andrew Cook
2019 (New Orleans) Annual Meeting

Contributed Session
Is there an inverse relationship between the importance of a research question and the scientific quality of a proposal to answer it? A reassurance for the UK's Public Health Research programme.

Session Details

Laura Lovato
2019 (New Orleans) Annual Meeting

Educational Session
It Takes a Village: Multi-Disciplinary Approach to Designing Stellar Data Collection Forms

Session Details

Jemma Hudson
2019 (New Orleans) Annual Meeting

Contributed Session
Joint modelling of quality of life and time-to-event data in an orthopaedic trial

Session Details

Rick Chappell
2019 (New Orleans) Annual Meeting

Contributed Session
Just-in-Time Consent: Efficiency vs. Ethics

Session Details

Yuanxi Jia
2019 (New Orleans) Annual Meeting

Contributed Session
Language Bias among Chinese-sponsored Drug-related Randomized Controlled Trials

Session Details

Jérôme Tanguy
2019 (New Orleans) Annual Meeting

Contributed Session
Learnings from the Adaptive Design journey

Session Details

Jessica Tran
2019 (New Orleans) Annual Meeting

Contributed Session
Legal and Ethical Considerations for the Inclusion of Limited English Proficient Individuals in Clinical Research: A Literature Review

Session Details

Cathryn Rankin
2019 (New Orleans) Annual Meeting

Contributed Session
Maintaining a Vigilance for Quality Data

Session Details

Richard Emsley
2019 (New Orleans) Annual Meeting

Contributed Session
Mediation analysis of complex interventions should reflect the trial design

Session Details

Eleanor Murray
2019 (New Orleans) Annual Meeting

Educational Session
Methods for Causal Inference from Randomized Trials with Loss to Follow-up or Non-adherence

Session Details

Laura Morrison
2019 (New Orleans) Annual Meeting

Contributed Session
Minimization as a Randomization Method

Session Details

Thomas Cook
2019 (New Orleans) Annual Meeting

Contributed Session
Missing Data and Sensitivity Analysis with Implications for Sample Size and Power of Randomized Clinical Trials.

Session Details

Kerenza Hood
2019 (New Orleans) Annual Meeting

Contributed Session
Moving innovations in neurofeedback in Mental Health into clinical care: developing a framework to enhance translation

Session Details

Isabelle Weir
2019 (New Orleans) Annual Meeting

Contributed Session
Multivariate meta-analysis model for the difference in restricted mean survival times

Session Details

Yuanyuan Kong
2019 (New Orleans) Annual Meeting

Contributed Session
Novel Mode and Effectiveness of International Collaborative Clinical Research Training Programs among Chinese Physicians

Session Details

Gurbakhshash Singh
2019 (New Orleans) Annual Meeting

Contributed Session
On Covariate Adaptive Randomization Methods in Acute Stroke Trials

Session Details

J Athene Lane
2019 (New Orleans) Annual Meeting

Contributed Session
Optimising recruitment in clinical trials in surgery including strategies for surgical trainees working together to achieve success

Session Details

Marcus Johnson
2019 (New Orleans) Annual Meeting

Contributed Session
Optimization of a Shared Network Drive to Increase Utilization Efficiency in a Clinical Research Setting

Session Details

Jennifer Gassman
2019 (New Orleans) Annual Meeting

Contributed Session
Optimizing data capture and management for tolerability outcomes: The BASE Study

Session Details

Rhiannon Macefield
2019 (New Orleans) Annual Meeting

Contributed Session
Outcome selection and reporting for innovative surgical procedures and devices: a review of current practice in IDEAL/IDEAL-D studies to inform the development of a core outcome set

Session Details

Patty Davis
2019 (New Orleans) Annual Meeting

Contributed Session
PARTICIPANT-DIRECTED DATA ENTRY VIA iPad IN SINGLE AND MULTI-SITE CLINICAL TRIALS

Session Details

Sarah Bruschi
2019 (New Orleans) Annual Meeting

Contributed Session
PERFORMING ELIGIBILITY CHECKS FOR COMPLICATED SCENARIOS

Session Details

Lauren Yesko
2019 (New Orleans) Annual Meeting

Session Proposal
Perspectives on Data Sharing: Preparing, Analyzing, and Conducting Secondary Data Analyses using Publicly Available Clinical Trial Data

Session Details

yves rosenberg
2019 (New Orleans) Annual Meeting

Session Proposal
Planning and Implementing Key Design Changes in Multicenter Clinical Trials: Lessons Learned from the ISCHEMIA trial experience

Session Details

David Kerr
2019 (New Orleans) Annual Meeting

Contributed Session
Points of Consideration for the Independence of DMCs and SDACs

Session Details

Linda Harrison
2019 (New Orleans) Annual Meeting

Contributed Session
Power Calculation for Cross-Sectional Stepped Wedge Cluster Randomized Trials with Variable Cluster Sizes

Session Details

Jennifer Le-Rademacher
2019 (New Orleans) Annual Meeting

Contributed Session
Practical Considerations for Trial Design using the Mean Survival Time Endpoint

Session Details

Sarah Tanveer
2019 (New Orleans) Annual Meeting

Contributed Session
Pragmatic Clinical Trials in Headache and Migraine Research: A Scoping Review

Session Details

Jill Fikowski
2019 (New Orleans) Annual Meeting

Contributed Session
Pre-implementation of a multi-center, Phase IV, Investigator initiated clinical trial: Experiences from the Canadian Research Initiative in Substance Misuse

Session Details

Eve Jelstrom
2019 (New Orleans) Annual Meeting

Contributed Session
Premature Site Closure during a Multi-site Clinical Trial

Session Details

Janel Barnes
2019 (New Orleans) Annual Meeting

Session Proposal
Preparing and Submitting Data to Open and Limited-Access Repositories

Session Details

Wentao Li
2019 (New Orleans) Annual Meeting

Contributed Session
Problematic registration, randomization, and analysis in randomized controlled trials: systematic review of Obstetrics and Gynaecology studies from an African country (2013-2018)

Session Details

Julia Collins
2019 (New Orleans) Annual Meeting

Contributed Session
Procedural Considerations for the Secure Remote Review of Executed Informed Consent Forms

Session Details

Marie Kay
2019 (New Orleans) Annual Meeting

Contributed Session
Process Mapping RCT Study Start-Up

Session Details

Erich Dress
2019 (New Orleans) Annual Meeting

Contributed Session
Prognosticating Outcomes and Nudging Decisions with Electronic Records in the ICU (PONDER-ICU) Trial: Implementation in a learning health system

Session Details

Fei Yuan
2019 (New Orleans) Annual Meeting

Contributed Session
Projecting post-trial life expectancy and life-gained: Using A Markov Microsimulation Model

Session Details

Eleanor Murray
2019 (New Orleans) Annual Meeting

Contributed Session
Proposed guidelines for causal inference from pragmatic randomized trials

Session Details

Lauren Balmert
2019 (New Orleans) Annual Meeting

Contributed Session
Quantile Lost Lifespan: A summary measure for time-to-event data

Session Details

Dustin Rabideau
2019 (New Orleans) Annual Meeting

Contributed Session
Randomization Inference for a Marginal Treatment Effect in Cluster Randomized Trials

Session Details

Patricia Morris
2019 (New Orleans) Annual Meeting

Contributed Session
Re-Enrolling Older Adults Eight Years after Original Study Ended: Issues & Solutions

Session Details

Fatima Alvi
2019 (New Orleans) Annual Meeting

Contributed Session
Reducing Adenoviral Patient Infected Days (RAPID) Study: Success in Masking Subjects and Clinicians to Treatment with Ophthalmic 5% Povidone-Iodine

Session Details

Eric Hardter
2019 (New Orleans) Annual Meeting

Contributed Session
Regulatory considerations for HHS-sponsored, non-drug human subjects research studies

Session Details

Bolaji Egbewale
2019 (New Orleans) Annual Meeting

Contributed Session
Relative sample size reduction of three standard statistical methods in the analysis of randomized controlled trials: a simulation study

Session Details

Melissa Plets
2019 (New Orleans) Annual Meeting

Contributed Session
Rethinking the Traditions of Trial Design: A Rare Cancer Basket Trial as a Motivating Example

Session Details

Hao Zhu
2019 (New Orleans) Annual Meeting

Session Proposal
Role of Model Informed Drug Development (MIDD) in Drug Development and Regulatory Evaluation

Session Details

Marion Campbell
2019 (New Orleans) Annual Meeting

Session Proposal
ROLE OF THE EXPERTISE-BASED DESIGN IN TRIALS OF NON-PHARMACOLOGICAL INTERVENTIONS

Session Details

Spencer Hey
2019 (New Orleans) Annual Meeting

Session Proposal
Safeguarding Public and Patient Trust in Pragmatic Trials Without Written Informed Consent

Session Details

Nicholas Seewald
2019 (New Orleans) Annual Meeting

Contributed Session
Sample size considerations for comparing dynamic treatment regimens in a sequentially-randomized trial with a continuous longitudinal outcome

Session Details

Lee Kennedy-Shaffer
2019 (New Orleans) Annual Meeting

Contributed Session
Sample size estimation for stratified individual and cluster randomized trials with binary outcomes

Session Details

David Zahrieh
2019 (New Orleans) Annual Meeting

Contributed Session
Sample size planning in the design of healthcare delivery intervention trials using the symbolic data framework

Session Details

Steven julious
2019 (New Orleans) Annual Meeting

Contributed Session
Sample sizes Group Clinical Trials with a Survival Endpoint - It’s Accrual World

Session Details

Mark Forrest
2019 (New Orleans) Annual Meeting

Contributed Session
Scaling the communication management hurdle: Communications Manager

Session Details

Julia Collins
2019 (New Orleans) Annual Meeting

Educational Session
Site Selection for Clinical Trials: Tips, Tricks and Process Considerations

Session Details

John Nichols
2019 (New Orleans) Annual Meeting

Contributed Session
SITE TRACKING SYSTEM FOR ADMINISTRATION AND ORGANIZATION OF CLINICAL SITE-SPECIFIC INFORMATION

Session Details

Thomas Cook
2019 (New Orleans) Annual Meeting

Contributed Session
Statistical Approaches for Summarizing the Clinical Event Reporting and Adjudication Process.

Session Details

Jody Ciolino
2019 (New Orleans) Annual Meeting

Educational Session
Statistical Concepts in Clinical Trials for Non-Statisticians

Session Details

Lu Mao
2019 (New Orleans) Annual Meeting

Contributed Session
Statistical Inference for Complex Time to Event Outcomes under Non-Randomized Cohorts with Application to the INVESTED Trial

Session Details

Leila Rooshenas
2019 (New Orleans) Annual Meeting

Educational Session
Strategies for optimizing recruitment to randomized clinical trials

Session Details

Margaret Crawford
2019 (New Orleans) Annual Meeting

Contributed Session
Surmounting Barriers with Targeted Solutions: Launching the Pharmacotherapies for Alcohol and Substance Abuse Consortium

Session Details

Victoria Shepherd
2019 (New Orleans) Annual Meeting

Contributed Session
Surrogate decision-making for clinical trials: a qualitative exploration of surrogate decision-makers’ experiences

Session Details

Julie Qidwai
2019 (New Orleans) Annual Meeting

Session Proposal
Switching Boats Mid-Stream: Maintaining Continuity in a Large Clinical Trials Network in the Face of Change

Session Details

Clement Ma
2019 (New Orleans) Annual Meeting

Contributed Session
TARGET-CRM: a novel adaptive dose-escalation design for targeted therapies with applications in pediatric oncology

Session Details

Fei Chen
2019 (New Orleans) Annual Meeting

Contributed Session
Testing of Multiple Survival Endpoints in a Group Sequential Design – Control of Familywise Error in CREDENCE

Session Details

Nicole Edgar
2019 (New Orleans) Annual Meeting

Contributed Session
The BEACON Study: Protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem solving therapy in men who present with intentional self-harm to Emergency Departments in Ontario.

Session Details

Catherine Olivier
2019 (New Orleans) Annual Meeting

Contributed Session
The Challenge of Innovation: Considerations for implementing two-way text messaging for primary outcome data collection in clinical trials

Session Details

Amy Dwy
2019 (New Orleans) Annual Meeting

Session Proposal
THE COLLABORATION BETWEEN DATA MANAGERS AND MONITORS IN RISK BASED MONITORING IN INTERNATIONAL STUDIES

Session Details

Charles Opondo
2019 (New Orleans) Annual Meeting

Contributed Session
The Combined Protocol for Acute Malnutrition Study: a cluster randomized non-inferiority trial in Kenya and South Sudan

Session Details

David DeMets
2019 (New Orleans) Annual Meeting

Session Proposal
The Coronary Drug Project (CDP): Looking Back 50 Years

Session Details

Adelaide Doussau
2019 (New Orleans) Annual Meeting

Contributed Session
The Ethics of Placebo Sequential Parallel Comparison Design

Session Details

Greg Ball
2019 (New Orleans) Annual Meeting

Session Proposal
The Global Regulatory Landscape and a Safety Mindset: Medical Judgment and Decision-Making within a Quantitative Framework

Session Details

Brooke Maracle
2019 (New Orleans) Annual Meeting

Contributed Session
The Influence of Institution Accrual on Patient Survival in Canadian Cancer Clinical Trials

Session Details

Catherine Meyers
2019 (New Orleans) Annual Meeting

Session Proposal
The Landscape of Embedded Pragmatic Clinical Trials in the US: Focus on Opioid Use and Pain Management

Session Details

Melanie Bell
2019 (New Orleans) Annual Meeting

Contributed Session
The mixed model for repeated measures for cluster randomized trials (MMRM-CRT): a simulation study investigating bias and type I error with missing continuous data

Session Details

Karla Hemming
2019 (New Orleans) Annual Meeting

Session Proposal
The multiple-period cluster randomised cross-over design for comparative effectiveness research: statistical and ethical issues

Session Details

Krista Valladares
2019 (New Orleans) Annual Meeting

Contributed Session
The NeuroNEXT Model: Efficiencies Gained by Deploying an Embedded Research Administrator

Session Details

Jonathan Kimmelman
2019 (New Orleans) Annual Meeting

Session Proposal
The United States’ Right-To-Try Legislation: Implications for Clinical Trials

Session Details

ken cheung
2019 (New Orleans) Annual Meeting

Session Proposal
Training the future generation of clinical trial biostatisticians

Session Details

Claire Cochran
2019 (New Orleans) Annual Meeting

Contributed Session
Traumatic Decisions; Research Recruitment and Randomisation in an Acute Emergency Setting

Session Details

Alison McDonald
2019 (New Orleans) Annual Meeting

Educational Session
Trial Close 0ut and Archiving

Session Details

Rebecca Lewis
2019 (New Orleans) Annual Meeting

Contributed Session
Trial salvage: Pragmatic design adaptation in response to recruitment challenges

Session Details

Edward Mayerson
2019 (New Orleans) Annual Meeting

Contributed Session
Trials, Tribulations, and Triumphs in Coordinating a “Not Otherwise Categorized” Cohort in an Umbrella Trial for Rare Cancers

Session Details

Rob Basmadjian
2019 (New Orleans) Annual Meeting

Contributed Session
UGT2B17, exemestane metabolism, and their association with physical health-related quality of life in postmenopausal women participating in the Mammary Prevention 3 Trial

Session Details

Peter Kaufmann
2019 (New Orleans) Annual Meeting

Session Proposal
Unintended consequences of participant engagement in clinical trials involving behavioral interventons.

Session Details

Giulia Lorenzoni
2019 (New Orleans) Annual Meeting

Contributed Session
Use of wearable devices to monitor physical activity in clinical studies: the CAPABILITY study protocol

Session Details

Jeffrey McCrindle
2019 (New Orleans) Annual Meeting

Contributed Session
Using AI and Natural Language Generation to Automate Pharmaceutical Clinical Study Reports

Session Details

Maria Pufulete
2019 (New Orleans) Annual Meeting

Session Proposal
Using observational healthcare data to emulate randomized trials

Session Details

Shaun Treweek
2019 (New Orleans) Annual Meeting

Educational Session
Using Studies Within a Trial (SWATs) to increase the evidence base for trial process decision-making

Session Details

David Klements
2019 (New Orleans) Annual Meeting

Contributed Session
Utilizing cloud-based software to increase efficiency and reduce errors and increase efficiency in communication during the conduct of multi-site clinical trials

Session Details

Kimberley Goldsmith
2019 (New Orleans) Annual Meeting

Session Proposal
What works for whom and why: the future for trials of complex interventions

Session Details

Mahesh Parmar
2018 (Portland) Annual Meeting

Trial of the Year Award
The Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy (STAMPEDE, NCT00268476)

Fan-fan Yu, Kathleen Reape
2018 (Portland) Annual Meeting

Trial of the Year Award
Efficacy and Safety of Voretigene Neparvovec (AAV2-hRPE65v2) in Patients with RPE65-mediated Inherited Retinal Dystrophy

William C. Cushman
2018 (Portland) Annual Meeting

Founders Lecture
Major VA and NHLBI Clinical Trials That Impacted the Management of Hypertension

Susan Halabi
2018 (Portland) Annual Meeting

Fellows Presentation
Presentation of the Class of 2018 Fellows

James J. Dignam
2018 (Portland) Annual Meeting

Award Presentation
Thomas C. Chalmers Scholarship and Sylvan Green Awards

Steven Goodman
2018 (Portland) Annual Meeting

Curtis Meinert Lecture
Research reproducibility and research reform: lessons from clinical trials

Ted Karrison, PhD
2018 (Portland) Annual Meeting

Presidential Welcome
Welcome - 2017-18 SCT President

Nicola Mills
2018 (Portland) Annual Meeting

Session Proposal
Achieving the impossible? Case studies of successful recruitment to randomised clinical trials considered contentious or impossible

Session Details

Theodore Lystig
2018 (Portland) Annual Meeting

Session Proposal
Dynamic determination of a power prior parameter – the discount prior approach

Session Details

Roger J. Lewis
2018 (Portland) Annual Meeting

Session Proposal
Design of an Adaptive Trial of Extra-Corporeal Membrane Oxygenation for Refractory Out-of-hospital Cardiac Arrest (EROCA)

Session Details

Lehana Thabane
2018 (Portland) Annual Meeting

Session Proposal
In memory of Dave Sackett: Interim data sharing by data safety monitoring boards of trials (Alternative title: Dave Sackett’s last project on interim data sharing by DSMBs of trials)

Session Details

Catherine Dillon
2018 (Portland) Annual Meeting

Session Proposal
Optimizing investigational drug management to enhance clinical trial operation quality

Session Details

Jeremy Grimshaw
2018 (Portland) Annual Meeting

Session Proposal
Developing a framework for the ethical design and conduct of pragmatic trials: consultation with the clinical trials community

Session Details

Greg Ball
2018 (Portland) Annual Meeting

Session Proposal
Dynamic and Interactive Collaboration between Quantitative and Clinical Scientists: Towards a Better Way of Monitoring and Evaluating Safety Data during Clinical Development

Session Details

Jeremy Grimshaw
2018 (Portland) Annual Meeting

Session Proposal
Introducing the new CONSORT extension for the Stepped-Wedge Cluster Randomised Trial

Session Details

Professor Jeremy Grimshaw
2018 (Portland) Annual Meeting

Session Proposal
Designing Trials within Implementation Laboratories

Session Details

Frank Rockhold
2018 (Portland) Annual Meeting

Session Proposal
Open Sharing of Clinical Trial Data

Session Details

Caitlyn Meinzer
2018 (Portland) Annual Meeting

Session Proposal
Adaptive Timing of Interim Analysis for Primary Efficacy Outcome

Session Details

Kirsty Loudon
2018 (Portland) Annual Meeting

Contributed Session
“Treatment As Usual” as the comparator in Randomised Controlled Trials: A scoping review of the use of the term over the past five years in six international general medical trial journals.

Session Details

Katie Gillies
2018 (Portland) Annual Meeting

Contributed Session
‘It’s trying to manage the work’: a qualitative evaluation of recruitment processes within a UK multicentre trial

Session Details

Sharavi Peeramsetti
2018 (Portland) Annual Meeting

Contributed Session
“Essential data for Data Monitoring Committee (DMC) review – the ideal open and closed session reports”

Session Details

Barry Main
2018 (Portland) Annual Meeting

Contributed Session
“Forget-me-not” – a protocol for a pilot cluster randomised trial to pilot a core information set intervention for informed consent to invasive procedures including surgery

Session Details

Eric Hardter
2018 (Portland) Annual Meeting

Contributed Session
A “compound” problem: general strategies and key resources for the utilization of approved, commercially available drugs in a blinded, controlled clinical trial

Session Details

Boxian Wei
2018 (Portland) Annual Meeting

Contributed Session
A Bayesian Analysis of Small n Sequential Multiple Assignment Randomized Trials (snSMARTs)

Session Details

Graham Wheeler
2018 (Portland) Annual Meeting

Contributed Session
A BAYESIAN MODEL-FREE APPROACH TO COMBINATION THERAPY PHASE I TRIALS USING CENSORED TIME-TO-TOXICITY DATA

Session Details

Julia Collins
2018 (Portland) Annual Meeting

Contributed Session
A Comprehensive Customizable Site Readiness Checklist for Efficient Site Activation in a Clinical Trial

Session Details

Munya Dimairo
2018 (Portland) Annual Meeting

Contributed Session
A consensus-driven reporting guidance for adaptive clinical trials: an Adaptive designs CONSORT Extension (ACE)

Session Details

Xiaobo Zhong
2018 (Portland) Annual Meeting

Contributed Session
A Gate-keeping Test for Selecting Adaptive Interventions under General SMART Designs

Session Details

Beata Planeta
2018 (Portland) Annual Meeting

Contributed Session
A New Approach of Modeling Time in Longitudinal Studies Involving Infrequent and Unequally Spaced Measurements

Session Details

Qinshu Lian
2018 (Portland) Annual Meeting

Contributed Session
A Novel Bayesian Two-stage Design with Dynamic Historical Borrowing Using a Robust Network Meta-analytic-predictive Approach

Session Details

Brian Egleston
2018 (Portland) Annual Meeting

Contributed Session
A novel randomized Phase 2 trial design that constrains sample size by requiring a sufficient experimental response rate

Session Details

Haiyan Zheng
2018 (Portland) Annual Meeting

Contributed Session
A robust Bayesian meta-analytic approach for borrowing information across species in phase I clinical trials

Session Details

Andrew Forbes
2018 (Portland) Annual Meeting

Contributed Session
A simple relationship between power and expected confidence interval width

Session Details

Katherine Fairhurst
2018 (Portland) Annual Meeting

Contributed Session
A systematic analysis of UK nationally-funded surgical pilot and feasibility study protocols from the last 10 years to inform and optimise future surgical trials.

Session Details

Erik Doffagne
2018 (Portland) Annual Meeting

Contributed Session
A Targeted Approach to Medical and Safety Reviews

Session Details

Karla Hemming
2018 (Portland) Annual Meeting

Educational Session
A tutorial on sample size for efficient cluster, cluster cross-over and stepped-wedge randomised trials; including introduction to a practical on-line “app”

Session Details

Michael Grayling
2018 (Portland) Annual Meeting

Contributed Session
A two-stage version of Fisher’s exact test for multi-arm trials with binary outcome variables

Session Details

Kelly Miller
2018 (Portland) Annual Meeting

Contributed Session
A UNIQUE COLLABORATION FOR A DATA COORDINATING CENTER

Session Details

Elizabeth Colantuoni
2018 (Portland) Annual Meeting

Contributed Session
Accounting for baseline prognostic variables and patient drop-out in the analysis of longitudinal outcomes within randomized trials for Alzheimer’s Disease

Session Details

Kelsey Grantham
2018 (Portland) Annual Meeting

Contributed Session
Accounting for measurement times with a non-uniform correlation structure in sample size determination for multiple-period cluster randomised trials

Session Details

Keaton Somerville
2018 (Portland) Annual Meeting

Contributed Session
ACHIEVING PROJECTED DATABASE LOCK IN A MULTI-SITE STUDY - A REPORT FROM A NIDA CTN STUDY

Session Details

Ajar Kochar
2018 (Portland) Annual Meeting

Contributed Session
ADAPTABLE - A Patient-Centered, Pragmatic Randomized Clinical Trial

Session Details

Laura Flight
2018 (Portland) Annual Meeting

Contributed Session
Adaptive Design Clinical Trials and their Impact on the Health Economic Analysis of Healthcare Technologies - A Qualitative Study

Session Details

Christopher S. Coffey
2018 (Portland) Annual Meeting

Educational Session
Adaptive Designs - Overview, Hurdles, & Examples

Session Details

Ben Saville, Ph.D.
2018 (Portland) Annual Meeting

Educational Session
Adaptive Multi-arm Platform Trials

Session Details

Jonathan Chipman
2018 (Portland) Annual Meeting

Contributed Session
Adaptively Monitoring Clinical Trials with Second-Generation p-values

Session Details

Jiajun Wen
2018 (Portland) Annual Meeting

Contributed Session
Adverse events in 103 randomized trials on 1st line glaucoma eye drops

Session Details

Stephanie Wellford
2018 (Portland) Annual Meeting

Contributed Session
All Hands on Deck for Eligibility Checks

Session Details

Chen Hu
2018 (Portland) Annual Meeting

Session Proposal
Alternatives to Conventional Survival Analysis Metrics for Clinical Trials

Session Details

Kandi Velarde
2018 (Portland) Annual Meeting

Contributed Session
An Initiative Using Informatics to Facilitate Clinical Research Planning and Recruitment in the VA Health Care System

Session Details

Jane Candlish
2018 (Portland) Annual Meeting

Contributed Session
Analysis methods for individually randomised trials with partial clustering of outcomes

Session Details

Heidi Christ-Schmidt
2018 (Portland) Annual Meeting

Contributed Session
Analysis of studies when rescue therapy censors data

Session Details

Joseph Rausch
2018 (Portland) Annual Meeting

Contributed Session
Analyzing treatment effects and moderators in randomized pre-post clinical trials

Session Details

Jennifer Le-Rademacher
2018 (Portland) Annual Meeting

Contributed Session
Application of Multi-State Models in Cancer Clinical Trials

Session Details

Jennifer Goldsack
2018 (Portland) Annual Meeting

Contributed Session
Applying Measurement Science to the Development of Technology-Derived Novel Endpoints for use in Clinical Trials

Session Details

Daniele Bottigliengo
2018 (Portland) Annual Meeting

Contributed Session
Assessing the external validity of Randomized Clinical Trials: inverse probability weighting approaches on type-2 diabetes data

Session Details

Hiroko Dodge
2018 (Portland) Annual Meeting

Contributed Session
Behavioral RCT using frequent social interaction to enhance cognitive reserve

Session Details

Cristina Murray-Krezan
2018 (Portland) Annual Meeting

Contributed Session
BUILDING THE FOUNDATION FOR A STATISTICS AND DATA COORDINATING CENTER WITH LIMITED RESOURCES: THE HERO STUDY, A NATIONWIDE MULTICENTER RANDOMIZED HEPATITIS C TREATMENT TRIAL

Session Details

Benjamin Carlisle
2018 (Portland) Annual Meeting

Contributed Session
BURDEN AND CLINICAL IMPACT OF COMBINATION THERAPY EXPLORATION FOR NEW ANTICANCER DRUGS

Session Details

Adina Stoica
2018 (Portland) Annual Meeting

Contributed Session
Calculating Antiretroviral Drug Resistance: An Innovative Open-Source Tool

Session Details

Rachel Weber
2018 (Portland) Annual Meeting

Contributed Session
CENTRALIZED SOURCE DOCUMENT REVIEW: AN EFFECTIVE TOOL FOR REMOTE REVIEW OF DIGITIZED PAPER SOURCE DOCUMENTS

Session Details

Wendy Seiferheld
2018 (Portland) Annual Meeting

Contributed Session
Challenges and Lessons Learned from Engaging the ClinicalTrials.gov Protocol Registration and Results System (PRS): An NRG Oncology Experience

Session Details

Shelly Lensing
2018 (Portland) Annual Meeting

Contributed Session
Challenges and Successes in Recruitment of HIV Infected Persons to a Cancer Prevention Study

Session Details

Roberta Scherer
2018 (Portland) Annual Meeting

Contributed Session
Challenges in conducting a multi-center trial in US military hospitals

Session Details

Melissa Plets
2018 (Portland) Annual Meeting

Contributed Session
Challenges in Conducting DART (S1609), a Pioneer Basket Trial for Rare Cancers in a Cooperative Group Setting

Session Details

Jeannette Lee
2018 (Portland) Annual Meeting

Contributed Session
Challenges of Conducting a Clinical Trial in Youth Correctional Facilities

Session Details

Andrew Waberski
2018 (Portland) Annual Meeting

Contributed Session
Challenges with Conducting a Trial of Opioid Administration during Anesthesia in Pediatric Patients Undergoing Cardiac Surgery

Session Details

Kehao Zhu
2018 (Portland) Annual Meeting

Contributed Session
Characteristics and trends of industry sponsored clinical trials with a DMC – insights from ClinicalTrials.gov

Session Details

Jody Ciolino
2018 (Portland) Annual Meeting

Contributed Session
Choosing a Balancing Criterion for Complex Cluster-Randomized Trials with Continuous Baseline Variables

Session Details

Rui Wu
2018 (Portland) Annual Meeting

Contributed Session
Classifying No Improvement in Visual Acuity in Children with Amblyopia Using Simulations

Session Details

Barbara H. Braffett
2018 (Portland) Annual Meeting

Session Proposal
Clinical Studies with Long-term Follow-up: Experiences and Lessons Learned

Session Details

Jidong Jia
2018 (Portland) Annual Meeting

Session Proposal
Clinical Trials in China – Opportunities and Challenges for International Collaboration

Session Details

Nisha Grover
2018 (Portland) Annual Meeting

Contributed Session
Collaborative Approach to Conduct User Testing by Non-technical Research Staff

Session Details

GEORGE KITSARAS
2018 (Portland) Annual Meeting

Contributed Session
Collection of real-time data from participants – interactive text surveys

Session Details

Walter Ambrosius
2018 (Portland) Annual Meeting

Contributed Session
Combining SAS and LaTeX for DSMB report generation: The ENRGISE Pilot Study

Session Details

Katherine Guthrie
2018 (Portland) Annual Meeting

Contributed Session
Comparison of mass mailings to Facebook advertising for recruitment of midlife women with bothersome vaginal symptoms

Session Details

Valerie Durkalski-Mauldin
2018 (Portland) Annual Meeting

Session Proposal
Competing with RVUs: How to successfully balance clinical research and clinical practice for the academic clinical principal investigator

Session Details

Taylor Swankie
2018 (Portland) Annual Meeting

Contributed Session
Conducting High-Impact, High-Quality Clinical Trials: Site Staff Training as a Component of Quality

Session Details

Claire Snowdon
2018 (Portland) Annual Meeting

Contributed Session
Conducting Non-commercial Clinical Trials Internationally - Experiences of a UK based Academic Clinical Trials Unit

Session Details

Andrew Forbes
2018 (Portland) Annual Meeting

Session Proposal
Covariate constrained randomisation for the design of parallel and stepped wedge cluster trials

Session Details

Ayon Mukherjee
2018 (Portland) Annual Meeting

Contributed Session
Covariate-Adjusted Response-Adaptive Designs for Weibull Distributed Survival Responses

Session Details

Li Chen
2018 (Portland) Annual Meeting

Session Proposal
Current Development of Adaptive Designs in Clinical Trials

Session Details

Andrew Forbes
2018 (Portland) Annual Meeting

Contributed Session
Decomposition of the treatment effect estimator in stepped wedge trials: Understanding the horizontal and vertical contributions

Session Details

Ludovic Trinquart
2018 (Portland) Annual Meeting

Contributed Session
Design Analyses of Randomized Clinical Trials Supporting FDA Cancer Drug Approvals

Session Details

Amanda Farrin
2018 (Portland) Annual Meeting

Educational Session
Design and Conduct of Efficient, Innovative Pilot & Feasibility Studies for Complex Interventions

Session Details

Jonathan Cook
2018 (Portland) Annual Meeting

Contributed Session
Design and optimal use of the expertise-based randomised controlled trial design

Session Details

Keith Pauls
2018 (Portland) Annual Meeting

Contributed Session
Design of an Electronic cIRB Submission Module Integrated Within a Clinical Trial Management System

Session Details

Isabelle Weir
2018 (Portland) Annual Meeting

Contributed Session
Design of Non-inferiority Randomized Trials Using the Difference in Restricted Mean Survival Times

Session Details

Lynn Sleeper
2018 (Portland) Annual Meeting

Contributed Session
DESIGN OF THE TEAMMATE TRIAL FOR CHILDREN WITH HEART TRANSPLANT AND DEVELOPMENT OF A NOVEL EFFICIENT ENDPOINT

Session Details

Lydia Foster
2018 (Portland) Annual Meeting

Contributed Session
Designing a Non-Inferiority Trial: Bayesian versus Frequentist Approach

Session Details

Jan Jansen
2018 (Portland) Annual Meeting

Contributed Session
Designing efficient trials in major trauma: the case study of REBOA

Session Details

Jennifer Goldsack
2018 (Portland) Annual Meeting

Contributed Session
Designing study protocols when mobile devices are used for data capture: Recommendations from the Clinical Trials Transformation Initiative

Session Details

Hakim-Moulay Dehbi
2018 (Portland) Annual Meeting

Contributed Session
Designing two- or three-arm randomized phase 2 selection trials using a margin of practical equivalence

Session Details

Jamie Jackson
2018 (Portland) Annual Meeting

Contributed Session
Determining Wear Time Validation Algorithms and Cutpoints: Challenges to Using Accelerometry in a Behavioral Randomized Clinical Trial of Adolescents with Congenital Heart Disease

Session Details

Heather Murray
2018 (Portland) Annual Meeting

Contributed Session
Developing a Remote Statistical Monitoring Plan

Session Details

Kaleab Abebe
2018 (Portland) Annual Meeting

Contributed Session
Development and implementation of a web-based SAE adjudication system.

Session Details

Kerry Avery
2018 (Portland) Annual Meeting

Contributed Session
Development of a core outcome set capturing key concepts relevant to safe and efficient evaluation of innovative invasive procedures

Session Details

Diane Whitham
2018 (Portland) Annual Meeting

Contributed Session
Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a mixed methods study

Session Details

Wendy Lawton
2018 (Portland) Annual Meeting

Contributed Session
Digital Strategies for Making Clinical Trials More Accessible: SWOG’s Website Redesign

Session Details

Mathew Margolis
2018 (Portland) Annual Meeting

Contributed Session
Do Site Visits Improve Participant Re-Engagement In Longitudinal Clinical Research?

Session Details

Clement Ma
2018 (Portland) Annual Meeting

Contributed Session
Dual-agent dose escalation methods for pediatric oncology clinical trials

Session Details

Ashley Hogan
2018 (Portland) Annual Meeting

Contributed Session
DYNAMIC MANUSCRIPT DEVELOPMENT AND TRACKING OF SCIENTIFIC PRODUCTIVITY AND IMPACT

Session Details

Zhibao Mi
2018 (Portland) Annual Meeting

Contributed Session
Empirical Assessment of Trial Futility in Multicenter Clinical Trials

Session Details

Carol Knott
2018 (Portland) Annual Meeting

Educational Session
Engaging ‘tricky’ sites: hints and tips

Session Details

Sangeetha Paramasivan
2018 (Portland) Annual Meeting

Contributed Session
Ethical aspects of clinical trials in India: a systematic review of research in the past two decades

Session Details

Cory Goldstein
2018 (Portland) Annual Meeting

Contributed Session
Ethical implications for pragmatic trials involving head-to-head comparisons of usual care interventions: an ethical analysis of the MINT trial

Session Details

Ralph Trane
2018 (Portland) Annual Meeting

Contributed Session
Evaluation of Diabetic Retinopathy Using the ETDRS Severity Scale – Is There A Gold Standard?

Session Details

Kimberley Goldsmith
2018 (Portland) Annual Meeting

Contributed Session
Evidenced based refinement of treatments – building mechanism evaluation into clinical trials

Session Details

Nicola Greenlaw
2018 (Portland) Annual Meeting

Contributed Session
Expanding on accepted wisdoms of statistical design and analysis - stratified randomized controlled trials

Session Details

Katie Gillies
2018 (Portland) Annual Meeting

Contributed Session
Exploring retention in clinical trials: A meta-ethnographic synthesis of studies reporting participant reasons for drop out

Session Details

Michelle Collinson
2018 (Portland) Annual Meeting

Contributed Session
EXPLORING THE HAWTHORNE EFFECT USING A BALANCED INCOMPLETE BLOCK DESIGN IN THE ASPIRE CLUSTER RANDOMISED CONTROLLED TRIALS

Session Details

Zhaomian Li
2018 (Portland) Annual Meeting

Contributed Session
Exploring the Impact of the False Discovery Rate to Correct for Multiple Comparisons

Session Details

Laura Lovato
2018 (Portland) Annual Meeting

Contributed Session
Exploring the potential of clinical trial data sharing: The SPRINT Challenge

Session Details

Loretta Davies
2018 (Portland) Annual Meeting

Contributed Session
Exploring treatment preference in trials which compare very different interventions: a pre-trial qualitative study

Session Details

Wynne Norton
2018 (Portland) Annual Meeting

Contributed Session
Extension of the PRECIS-2 tool to assist in planning trials of multi-level interventions

Session Details

Mallory Hacker
2018 (Portland) Annual Meeting

Contributed Session
Feasibility of a Seven-Day Therapeutic Washout in Early Stage Parkinson’s Disease

Session Details

Kaitlyn Cook
2018 (Portland) Annual Meeting

Contributed Session
Futility Assessment via the Conditional Power for Cluster-Randomized Trials with Time-to-Event Endpoints

Session Details

Melissa Schultz
2018 (Portland) Annual Meeting

Contributed Session
Graphical Summaries of Trial Conduct in DMC Reports

Session Details

Kristen Mason
2018 (Portland) Annual Meeting

Contributed Session
Heat Maps for Database Lock

Session Details

Heidi Gardner
2018 (Portland) Annual Meeting

Contributed Session
How do trialists go about designing their recruitment strategies? A qualitative interview study with trial stakeholders

Session Details

Allison Hirst, IDEAL Project Manager & Researcher
2018 (Portland) Annual Meeting

Educational Session
How to use IDEAL (Idea, Development, Exploration, Assessment and Long-term study) to improve surgical innovation research

Session Details

Asha Khachane
2018 (Portland) Annual Meeting

Contributed Session
IDEAL: Framework and Recommendations for Evaluation of Surgical Innovations

Session Details

Jody Ciolino
2018 (Portland) Annual Meeting

Contributed Session
Ideas in Randomization Methods for Complex Cluster-Randomized Trials

Session Details

Garrick Wallstrom
2018 (Portland) Annual Meeting

Contributed Session
Identification of High-efficacy Subgroups in Clinical Trials

Session Details

Rebecca Simpson
2018 (Portland) Annual Meeting

Contributed Session
Identifying subgroups of children with asthma who are at higher risk of having an unscheduled medical contact in September: A mixed methods study

Session Details

Thevaa Chandereng
2018 (Portland) Annual Meeting

Contributed Session
Imbalanced

Session Details

Erik Doffagne
2018 (Portland) Annual Meeting

Contributed Session
Implementing a Scalable Risk-Based Monitoring Strategy

Session Details

Lauren Yesko
2018 (Portland) Annual Meeting

Contributed Session
Implementing eCRFs in an Emergency Department environment: challenges, enhancements, and lessons learned

Session Details

Jeremy Wolff
2018 (Portland) Annual Meeting

Contributed Session
Implementing Standardized Assessments in EDC: Benefits and Challenges based on Experience of Integrating the PhenX Toolkit into a Clinical Trials Network

Session Details

Paul Brocklehurst
2018 (Portland) Annual Meeting

Contributed Session
Improving implementation in Wales through 'The Forum': an update

Session Details

Sian Cousins
2018 (Portland) Annual Meeting

Contributed Session
Improving RCTs in invasive procedures; a proposed new definition of invasive procedures

Session Details

Shaun Treweek
2018 (Portland) Annual Meeting

Contributed Session
Improving the evidence base for trial process decision-making: Studies Within A Trial (SWAT) and why we should be coordinating and doing more of them

Session Details

Dr. Marjorie Jenkins
2018 (Portland) Annual Meeting

Session Proposal
Including Pregnant and Lactating Women in Clinical Trials: Controversies, Challenges and Opportunities

Session Details

Victoria Trapani
2018 (Portland) Annual Meeting

Contributed Session
Incorporating Aging Measures in a Long-term Multicenter Observational Study: Training and Certification Procedures

Session Details

Colin Begg
2018 (Portland) Annual Meeting

Session Proposal
Informed Consent and Innovative Trial Designs

Session Details

Allison Furey
2018 (Portland) Annual Meeting

Contributed Session
Innovative Use of Stacked Area Plots in DMC Reporting

Session Details

Wenle Zhao
2018 (Portland) Annual Meeting

Contributed Session
Integrated Drug Tracking Module in EDC-CTMS for Operation Quality Assurance in a Large Multicenter Trial

Session Details

Jaemyung Kim
2018 (Portland) Annual Meeting

Contributed Session
Integrating Neuroimaging Central Repository and Tracking in Clinical Trial Management System

Session Details

Brian Burke
2018 (Portland) Annual Meeting

Contributed Session
Integrating New Site Coordinators in an Ongoing Long-Term Multi-Site Observational Trial

Session Details

Michael Frasketi
2018 (Portland) Annual Meeting

Contributed Session
Interactive Reporting and Visualization of Standardized Clinical Data

Session Details

Toshimitsu Hamasaki
2018 (Portland) Annual Meeting

Contributed Session
Interim evaluation of efficacy or futility in group-sequential trials with two time-to-event outcomes

Session Details

Brett Hanscom
2018 (Portland) Annual Meeting

Contributed Session
Interim Monitoring using Adaptive, Time-Varying Non-Inferiority Margins

Session Details

Katie Gillies
2018 (Portland) Annual Meeting

Contributed Session
Interventions to improve retention to clinical trials: a behavioural analysis of effective interventions.

Session Details

Stephen Nash
2018 (Portland) Annual Meeting

Contributed Session
Introducing a new Stata package for sample size calculation in trials where the outcome is a rate

Session Details

Jimmy Le
2018 (Portland) Annual Meeting

Contributed Session
Is intraocular pressure, a surrogate outcome, important to patients with glaucoma?

Session Details

Dixie Ecklund
2018 (Portland) Annual Meeting

Session Proposal
Keeping Your Eye on the Endpoints: Study Closeout Starts from the Beginning

Session Details

Heather Kopetskie
2018 (Portland) Annual Meeting

Contributed Session
Leveraging Existing Databases for Clinical Trial Data

Session Details

Sudha Raman
2018 (Portland) Annual Meeting

Contributed Session
Leveraging the Electronic Health Record in a Global Outcomes Trial: Design and Rationale of the HARMONY Outcomes EHR Ancillary

Session Details

Gail Mallett
2018 (Portland) Annual Meeting

Contributed Session
Maternal Characteristics Associated with Consent and Reasons for Refusal in a Randomized Controlled Trial in Pregnancy

Session Details

Denise Esserman
2018 (Portland) Annual Meeting

Contributed Session
MEASURING THE IMPACT OF PATIENT PREFERENCE IN CLINICAL TRIALS

Session Details

Michael Frasketi
2018 (Portland) Annual Meeting

Contributed Session
Medical Image Integration with Clinical Research Systems

Session Details

Virginia Howard
2018 (Portland) Annual Meeting

Contributed Session
Methods, Successes, and Lessons Learned from Centralized Cognitive Assessment in a Multicenter Clinical Trial of Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis (CREST-2)

Session Details

Fang-Shu Ou
2018 (Portland) Annual Meeting

Contributed Session
Milestone prediction for time-to-event endpoint monitoring in clinical trials

Session Details

Brooke Rabe
2018 (Portland) Annual Meeting

Contributed Session
Missing data imputation methods in non-inferiority trials: a simulation study

Session Details

Elaine Pascoe
2018 (Portland) Annual Meeting

Contributed Session
MISSING DATA IN THE COMPONENTS OF A BINARY COMPOSITE ENDPOINT: IMPLICATIONS FOR THE COMPOSITE

Session Details

Virginia Nido
2018 (Portland) Annual Meeting

Contributed Session
MOBILE TECHNOLOGY AND CLINICAL TRIALS: PATIENT PERSPECTIVES AND OPPORTUNITIES TO REDUCE THE BURDEN OF PARTICIPATION

Session Details

Danni Liu
2018 (Portland) Annual Meeting

Contributed Session
Modeling Correlated Ocular Outcomes when Both Eyes from Some but Not All Participants are Enrolled

Session Details

Brian Burke
2018 (Portland) Annual Meeting

Contributed Session
Monitoring and Adjudication of Comorbidities in a Multi-Center Observational Study of Youth with Type 2 Diabetes

Session Details

Jennifer Gassman
2018 (Portland) Annual Meeting

Contributed Session
Monitoring and Reporting blood pressure data quality and data completeness and blood pressure treatment arm separation for the Blood Pressure in Dialysis (BID) Pilot Study

Session Details

Jason McCoy
2018 (Portland) Annual Meeting

Contributed Session
Monitoring Interactive Response Technology Vendor Implemented Randomization and Dosing Systems

Session Details

Anna Bowers
2018 (Portland) Annual Meeting

Contributed Session
MONITORING OF MEDICAL EVENTS AND ADJUDICATION THROUGH CUSTOMIZABLE DIGITAL WORKFLOWS IN THE DIABETES PREVENTION PROGRAM OUTCOMES STUDY (DPPOS)

Session Details

Haley Hedlin
2018 (Portland) Annual Meeting

Contributed Session
Monitoring rare events during an ongoing clinical trial

Session Details

Stacey Slone
2018 (Portland) Annual Meeting

Contributed Session
My Data, Your Data, Where’s the Data?

Session Details

Jonathan Cook
2018 (Portland) Annual Meeting

Contributed Session
New guidance on specifying the target difference (“effect size”) for a RCT

Session Details

Claire Boyle
2018 (Portland) Annual Meeting

Contributed Session
NHANES as a Comparator Cohort

Session Details

Ying Yuan
2018 (Portland) Annual Meeting

Educational Session
Novel Adaptive Designs for Phase I and II Clinical Trials

Session Details

Paola Berchialla
2018 (Portland) Annual Meeting

Contributed Session
Objective inference to adjust for baseline covariates in the analysis of randomized controlled trials for increasing efficiency

Session Details

Daniel Benjamin
2018 (Portland) Annual Meeting

Contributed Session
On the Accuracy of Oncology Experts’ Predictions about Safety in Randomized Cancer Trials

Session Details

Pamela Tenaerts
2018 (Portland) Annual Meeting

Contributed Session
One decade of impact. One vision ahead. Optimizing the power of public-private partnership: Lessons learned from the Clinical Trials Transformation Initiative

Session Details

Steven Edland
2018 (Portland) Annual Meeting

Contributed Session
Optimal Composite Endpoints for Clinical Trials of Chronic Progressive Disease

Session Details

J Athene Lane
2018 (Portland) Annual Meeting

Contributed Session
Optimising recruitment in clinical trials in surgery: how do surgical trainees working together achieve success?

Session Details

Sian Cousins
2018 (Portland) Annual Meeting

Contributed Session
Optimising the design of placebo-controlled RCTs of invasive procedures: An analysis of published RCTs

Session Details

Jay Siegel
2018 (Portland) Annual Meeting

Contributed Session
Optimizing Phase II Clinical Trials

Session Details

Jennifer Goldsack
2018 (Portland) Annual Meeting

Contributed Session
Optimizing the selection of mobile devices for data capture in clinical trials: Recommendations from the Clinical Trials Transformation Initiative

Session Details

Alice Biggane
2018 (Portland) Annual Meeting

Contributed Session
Participant Input in Core Outcome Set Development: Qualitative Study

Session Details

Caroline Hurley
2018 (Portland) Annual Meeting

Contributed Session
Perceived barriers and facilitators to Risk Based Monitoring in academic- led clinical trials – a mixed methods study

Session Details

Graham Wheeler
2018 (Portland) Annual Meeting

Contributed Session
PHASE I TRIALS OF IMMUNOTHERAPIES AND MOLECULARLY TARGETED AGENTS: WHAT DESIGNS ARE USED, AND HOW WELL ARE THEY REPORTED?

Session Details

Jose Jimenez
2018 (Portland) Annual Meeting

Contributed Session
Phase I/II Bayesian adaptive design with drug combinations and time-to-event data

Session Details

Jonathan Cook
2018 (Portland) Annual Meeting

Session Proposal
Placebo and sham controlled trials in surgery and in other invasive procedures: lessons, ethics and design issues

Session Details

RANI JAYSWAL
2018 (Portland) Annual Meeting

Contributed Session
Practical Methods for Utilization of Biomarkers to Assess Cancer Prognosis

Session Details

Scott Evans
2018 (Portland) Annual Meeting

Session Proposal
Pragmatic Benefit:risk Assessment in Clinical Trials: A New Paradigm Using Pairwise Comparison of Patients

Session Details

Paula Darby Lipman
2018 (Portland) Annual Meeting

Contributed Session
Pragmatic trial management: Exploring evidence for trial planning milestones

Session Details

Kirsty Loudon
2018 (Portland) Annual Meeting

Educational Session
Precisely how can this tool help investigators design trials to achieve practical answers to “real world” questions?

Session Details

Sonia Davis Thomas
2018 (Portland) Annual Meeting

Contributed Session
Predictive modeling of outcomes in a clinical trial with missing baseline data

Session Details

Heidi Gardner
2018 (Portland) Annual Meeting

Contributed Session
Presenting user-tested evidence based tools to support development of trial recruitment strategies

Session Details

on behalf of Bluebelle Study Group
2018 (Portland) Annual Meeting

Contributed Session
PSYCHOMETRIC AND INITIAL CLINICAL VALIDATION OF THE BLUEBELLE WOUND HEALING QUESTIONNAIRE (WHQ): A NEW OUTCOME MEASURE FOR POST-DISCHARGE ASSESSMENT OF WOUNDS FOR SURGICAL SITE INFECTION

Session Details

Elizabeth Wright
2018 (Portland) Annual Meeting

Contributed Session
Randomized Clinical Trial Abstracts Submitted to Major Medical Meetings: Do They Include Trial Registration Numbers and Conform to Consort Guidelines?

Session Details

Mackenzie Dome
2018 (Portland) Annual Meeting

Contributed Session
Reach Out: Randomized Clinical Trial of Emergency Department-Initiated Hypertension Behavioral Intervention Connecting Multiple Health Systems

Session Details

Yong Zang
2018 (Portland) Annual Meeting

Session Proposal
Recent Developments in Umbrella, Basket and Platform Trial Designs

Session Details

Karen Bracken
2018 (Portland) Annual Meeting

Contributed Session
Recruiting men aged 50-74 years to a large diabetes prevention trial: the effectiveness of traditional vs online promotional strategies

Session Details

Jamie Soames
2018 (Portland) Annual Meeting

Contributed Session
Reducing unnecessary antibiotic prescribing in primary care: a point-of-care electronic intervention using electronic healthcare records (REDUCE Trial)

Session Details

Shing Lee
2018 (Portland) Annual Meeting

Session Proposal
Reproducible Clinical Trials

Session Details

Melanie Bell
2018 (Portland) Annual Meeting

Contributed Session
Responder analysis with missing data: comparison of two imputation techniques in the context of randomized controlled trials

Session Details

Clare Relton
2018 (Portland) Annual Meeting

Contributed Session
RETHINKING THE ARCHITECTURE OF PRAGMATIC TRIALS

Session Details

Amber Randall
2018 (Portland) Annual Meeting

Contributed Session
Risk-based Validation in Clinical Trial Reporting: Focus on What Matters Most

Session Details

Simon Day (tentative)
2018 (Portland) Annual Meeting

Session Proposal
Role of Data Monitoring Committees in Complicated Trials

Session Details

David Collister
2018 (Portland) Annual Meeting

Contributed Session
Run-in periods in randomized controlled trials of chronic diseases: a meta-epidemiologic study

Session Details

Wayne Feng
2018 (Portland) Annual Meeting

Contributed Session
Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study

Session Details

Wei Wang
2018 (Portland) Annual Meeting

Contributed Session
Safety Assessment Committee Joins with Data Monitoring Committee - Safety Is the New Efficacy

Session Details

Maria Ciarleglio
2018 (Portland) Annual Meeting

Contributed Session
Sample Size Estimation Using a Hybrid Classical and Bayesian Procedure

Session Details

DANILA AZZOLINA
2018 (Portland) Annual Meeting

Contributed Session
Sample size issues for non-inferiority clinical trials with multiple primary endpoints

Session Details

Jennifer Goldsack
2018 (Portland) Annual Meeting

Contributed Session
Selecting Technology Derived Novel Endpoints for Development and Inclusion in Clinical Trials

Session Details

Ying Liu
2018 (Portland) Annual Meeting

Contributed Session
SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIALS FOR COMPARING PERSONALIZED ANTIMICROBIAL STRATEGIES (SMART COMPASS)

Session Details

Sarah Finlayson
2018 (Portland) Annual Meeting

Contributed Session
Should we plan for the unplanned? Managing undesirable but unavoidable protocol amendments in clinical trials.

Session Details

Kaitlyn Antonelli
2018 (Portland) Annual Meeting

Contributed Session
Site Activation Processes Predictive of Enrollment Success in a Pragmatic Precision Medicine Study

Session Details

Karen Innes
2018 (Portland) Annual Meeting

Contributed Session
Site Initiation Training – What can be learned from evaluating this process from multicentre trials?

Session Details

Hyunsook Chin
2018 (Portland) Annual Meeting

Contributed Session
Site Investigator vs. Sponsor SAE Causality: Are they different?

Session Details

Shaun Treweek
2018 (Portland) Annual Meeting

Contributed Session
Sixty-eight studies and (nearly) nothin’ on: the poor state of the recruitment intervention methodology literature and what to do about it

Session Details

Marta Bofill Roig
2018 (Portland) Annual Meeting

Contributed Session
Sizing clinical trials with composite binary endpoints

Session Details

Riaz Qureshi
2018 (Portland) Annual Meeting

Contributed Session
Standardized Reporting of Randomized Clinical Trials for Systematic Reviews: Systematic Review Data Repository

Session Details

Rebecca Paulus
2018 (Portland) Annual Meeting

Educational Session
Statistical Graphs in SAS Using Graphics Template Language (GTL)

Session Details

Abigail Baldridge
2018 (Portland) Annual Meeting

Contributed Session
StatTag for Connecting R, SAS, and Stata to Word: A Practical Approach to Reproducibility

Session Details

Abigail Baldridge
2018 (Portland) Annual Meeting

Educational Session
StatTag for Connecting R, SAS, and Stata to Word: A Practical Approach to Reproducibility

Session Details

Heidi Gardner
2018 (Portland) Annual Meeting

Contributed Session
Strategies to improve participant recruitment to randomised controlled trials: A systematic review of non-randomised evaluations

Session Details

Adel Gomaa Ibrahim El Feky
2018 (Portland) Annual Meeting

Contributed Session
Strategies to improve participant retention to randomized controlled trials: what do non-randomized evaluations of retention strategies have to tell us?

Session Details

Tsedenia Bezabeh
2018 (Portland) Annual Meeting

Contributed Session
STREAMLINING THE PROTOCOL OVERSIGHT PROGRAM FOR MAXIMUM EFFICIENCY IN THE DIABETES PREVENTION PROGRAM OUTCOMES STUDY (DPPOS)

Session Details

Kimberley Goldsmith
2018 (Portland) Annual Meeting

Educational Session
Studying Treatment Mechanisms – A Whistle Stop Tour of Simple Mediation Analysis

Session Details

Eileen Stock
2018 (Portland) Annual Meeting

Contributed Session
Surveillance of Serious Adverse Events in a Multisite Clinical Trial utilizing VA Healthcare Administrative Data

Session Details

Anna Moseley
2018 (Portland) Annual Meeting

Contributed Session
SURVIVAL BY HISPANIC ETHNICITY AMONG CANCER PATIENTS PARTICIPATING IN SWOG CLINICAL TRIALS

Session Details

Jade Fiotto
2018 (Portland) Annual Meeting

Contributed Session
Telephonic Informed Consent for Point of Care (POC) Clinical Trials

Session Details

Letitia Perdue
2018 (Portland) Annual Meeting

Contributed Session
The Central IRB Experience in a Minimal Risk Observational Study

Session Details

William Wood
2018 (Portland) Annual Meeting

Contributed Session
THE CHALLENGES AND OPPORTUNITIES OF MOBILE TECHNOLOGY: A QUALITATIVE EXAMINATION OF INVESTIGATORS’ EXPERIENCES AND RECOMMENDATIONS

Session Details

Jonathan Gibb
2018 (Portland) Annual Meeting

Contributed Session
The Data Extract Verify File – an open source and cross platform XML file to verify data extracts

Session Details

Mary Putt
2018 (Portland) Annual Meeting

Contributed Session
The Habit Formation Trial to Evaluate Behavioral Economic Interventions to Reduce the Risk of Cardiovascular Disease: Lessons Learned

Session Details

Tianchen Qian
2018 (Portland) Annual Meeting

Session Proposal
The Micro-Randomized Trial Design for developing adaptive mobile health interventions

Session Details

Mitra Lewis
2018 (Portland) Annual Meeting

Contributed Session
The National Drug Abuse Treatment Clinical Trials Network (NDAT CTN) Strategic Planning Group on Retention: Lessons Learned and Best Practices

Session Details

Nicholas Seedorff
2018 (Portland) Annual Meeting

Contributed Session
The National Institute of Neurology Disorders and Stroke Clinical Trials Methodology Course: Outcomes of Trainees after 3 Years

Session Details

Yuko Palesch
2018 (Portland) Annual Meeting

Session Proposal
The Role of Central IRB vs DSMB in the Decision Making Process for Premature Termination or Enrollment Suspension of a Multicenter Trial

Session Details

Jessica Kasza
2018 (Portland) Annual Meeting

Contributed Session
The standard error of the treatment effect in stepped wedge trials when the within-cluster correlation structure is misspecified

Session Details

Andrea Viecelli
2018 (Portland) Annual Meeting

Contributed Session
The Standardized Outcomes in Nephrology – Hemodialysis (SONG-HD) Initiative: establishing a core outcome set for trials in patients on hemodialysis

Session Details

David Kerr
2018 (Portland) Annual Meeting

Contributed Session
The Ugly Truths of Today’s DMCs – and What the SDAC Can Do to Help

Session Details

Nicholas Fergusson
2018 (Portland) Annual Meeting

Contributed Session
The win ratio approach in kidney transplant trials

Session Details

Ales Kotalik
2018 (Portland) Annual Meeting

Contributed Session
The win ratio approach to the analysis of a composite outcome in the Multiple Risk Factor Intervention Trial

Session Details

Brian Traver
2018 (Portland) Annual Meeting

Contributed Session
Time-Course Graphics for Individual Subjects In DMC Reports

Session Details

David Kerr
2018 (Portland) Annual Meeting

Educational Session
Training the Next Generation of DMC Members and the Teams that Support Them

Session Details

Eve Jelstrom
2018 (Portland) Annual Meeting

Contributed Session
Translating Assessments in Clinical Trials Conducted in the US

Session Details

Claire Cochran
2018 (Portland) Annual Meeting

Contributed Session
Traumatic Decisions; Research Recruitment and Randomisation in an Acute Emergency Setting

Session Details

Roberta Scherer
2018 (Portland) Annual Meeting

Contributed Session
Treatment adherence in the Tinnitus Retraining Therapy Trial

Session Details

Lucy Beasant
2018 (Portland) Annual Meeting

Contributed Session
Treatment preference in pediatric randomised clinical trials: systematic review and qualitative synthesis

Session Details

Navneet Hakhu
2018 (Portland) Annual Meeting

Contributed Session
TWO FACTORS IMPACTING FORMULATION OF DATA MONITORING COMMITTEE RECOMMENDATIONS FOR ADAPTIVE DESIGN CLINICAL TRIALS

Session Details

Michael J. Grayling
2018 (Portland) Annual Meeting

Educational Session
Understanding adaptive designs through single-arm trials

Session Details

Katherine Fairhurst
2018 (Portland) Annual Meeting

Contributed Session
Understanding progression from an internal pilot to a main trial: exploring views and perceptions of key stakeholders.

Session Details

J athene Lane
2018 (Portland) Annual Meeting

Contributed Session
Understanding strategies and practices that influence retention in clinical trials through an interview study of trial staff in five multi-centre trials

Session Details

Lesley Curtis
2018 (Portland) Annual Meeting

Contributed Session
Understanding the Clinical Trial Enterprise’s Newest Trend: Incorporating Real-World Evidence into Randomized Clinical Trials

Session Details

Chin-Fu Hsiao
2018 (Portland) Annual Meeting

Contributed Session
Use of A Bayesian Approach to Incorporate Toxicity Consideration Into The Two Stage Design of Phase II Clinical Trials

Session Details

Brian Perry
2018 (Portland) Annual Meeting

Contributed Session
Use of Qualitative Data Analysis Software to Facilitate a Systematic Literature Review

Session Details

Patricia Morris
2018 (Portland) Annual Meeting

Contributed Session
Using a Professional Tracing Service to Locate Participants 6 Years After Study Close-out

Session Details

Jennifer Goldsack
2018 (Portland) Annual Meeting

Contributed Session
Using a single, central IRB for a nationwide pragmatic clinical trial using claims data

Session Details

Kathryn Jackson
2018 (Portland) Annual Meeting

Contributed Session
Using Composite Surrogate Baseline Variables in a Modified Covariate-Constrained Randomization Algorithm

Session Details

Pablo Serrano
2018 (Portland) Annual Meeting

Contributed Session
USING ELECTRONIC DATABASES TO INCREASE ACCRUAL TO GASTROINTESTINAL CANCER CLINICAL TRIALS

Session Details

Lin Wang
2018 (Portland) Annual Meeting

Contributed Session
Using FDA website and ClinicalTrials.gov to identify trials for network meta-analysis: A case study on first-line medications for glaucoma

Session Details

Ian Wadsworth
2018 (Portland) Annual Meeting

Contributed Session
Using model-based approaches for determining optimal dosing rules in children

Session Details

Ron Marks
2018 (Portland) Annual Meeting

Contributed Session
Using Phase 2 Clinical Trial Design to Enhance the Phase 3 Process

Session Details

Kellee Miller
2018 (Portland) Annual Meeting

Contributed Session
Using Qualitative Data to Develop and Refine Interventions

Session Details

Shaun Treweek
2018 (Portland) Annual Meeting

Educational Session
Using Studies Within a Trial (SWATs) to increase the evidence base for trial recruitment and retention decision-making

Session Details

Marcus Johnson
2018 (Portland) Annual Meeting

Contributed Session
Utilization of a Paired Comparison Analysis Framework to Inform and Prioritize Decision-Making in a Highly Matrixed Clinical Research Program

Session Details

Dagmar Salazar
2018 (Portland) Annual Meeting

Contributed Session
Utilizing a Robust and Comprehensive Locator Form as a Retention Tool in Clinical Trials

Session Details

Daniel Goldenholz
2018 (Portland) Annual Meeting

Contributed Session
Variability adjusted time to event (VATE) method for analysis of randomized clinical trials in epilepsy and other episodic diseases

Session Details

Shun Fu Lee
2018 (Portland) Annual Meeting

Contributed Session
Variations in Design of the Stepped Wedge Cluster Randomized Trial: illustration of statistical concepts using the Patient-Centered Care Transitions in Heart Failure (PACT-HF) Trial

Session Details

Alan Stevenson
2018 (Portland) Annual Meeting

Contributed Session
Video Adjudication in Clinical Trials: Enabling Distribution of Expertise and Accurate Scoring

Session Details

Catherine Meyers
2018 (Portland) Annual Meeting

Session Proposal
What Are We Learning from Pragmatic Clinical Trials? Design, Implementation and Analytic Strategies

Session Details

Isoken Odia
2018 (Portland) Annual Meeting

Contributed Session
WHAT IS THE EFFECT OF TREATMENT CROSSOVER ON AN INTENTION TO TREAT ANALYSIS IN A NON-INFERIORITY TRIAL?

Session Details

merrick.zwarenstein@ices.on.ca
2018 (Portland) Annual Meeting

Session Proposal
When pragmatism and reality collide: use of the PRECIS 1 and 2 tools in PCORI funded trials

Session Details

Kristen Wroblewski
2018 (Portland) Annual Meeting

Contributed Session
Why Not Buckley-James? A Simulation Study

Session Details

J. Michael Gaziano
2017 (Liverpool) Annual Meeting

Founders Lecture
The Million Veteran Program: A Modern Mega-Cohort within a Healthcare systemUsing Big Health Data to Improve Health Care

Jerry Wolinsky
2017 (Liverpool) Annual Meeting

Trial of the Year Award
ORATORIO

James J. Dignam
2017 (Liverpool) Annual Meeting

Award Presentation
Thomas C. Chalmers Scholarship and Sylvan Green Awards

Susan S. Ellenberg
2017 (Liverpool) Annual Meeting

Curtis Meinert Lecture
Clinical Trials in the Twenty-First Century: Ongoing Challenges and Emerging Issues

Will Meurer & Jon Nichols
2017 (Liverpool) Annual Meeting

Special Presentation
Opening Remarks, Program Scientific Committee Co-Chairs

Susan Halabi
2017 (Liverpool) Annual Meeting

Fellows Presentation
Presentation of the Class of 2017 Fellows

Siobhan Bourke
2017 (Liverpool) Annual Meeting

Contributed Session
Rituximab for the treatment of neuromyelitis optica: an application of individual patient data meta-analysis in a rare disease.

Session Details

Clare Clement
2017 (Liverpool) Annual Meeting

Contributed Session
"To have and to hold, from this day forward": Understanding current practice regarding retention of trial particpants

Session Details

Clare Clement
2017 (Liverpool) Annual Meeting

Contributed Session
‘Enquiry into how Qualitative Methods Influence Trials and their Yields’ (EQUITY): Exploring registered trials that include a reported qualitative component

Session Details

Loretta Davies
2017 (Liverpool) Annual Meeting

Contributed Session
“I struggle with equipoise”: a qualitative study exploring clinicians’ views of a randomised controlled trial (ACL SNNAP) prior to trial conduct

Session Details

Andrew Embleton
2017 (Liverpool) Annual Meeting

Contributed Session
“If a tree falls in a forest…”: Abstract view statistics as a measure of research impact

Session Details

Alex Nicolson
2017 (Liverpool) Annual Meeting

Contributed Session
“More than the Emperor’s new clothes”: Enhancing meaningful Patient and Public Involvement in Trial Oversight Committees through qualitative research with eight clinical trials facing challenges

Session Details

Mary Rauchenberger
2017 (Liverpool) Annual Meeting

Contributed Session
“Will you walk a little faster?” - Joining the database development dance

Session Details

Laura Pankhurst
2017 (Liverpool) Annual Meeting

Contributed Session
40 is the magic number

Session Details

Alexina Mason
2017 (Liverpool) Annual Meeting

Contributed Session
A Bayesian framework to address missing not at random data in longitudinal studies with multiple types of missingness

Session Details

Moreno Ursino
2017 (Liverpool) Annual Meeting

Contributed Session
A Bayesian weighted quasi-likelihood design for Phase I/II clinical trial with repeated dose administration in preterm newborns.

Session Details

Alba Realpe
2017 (Liverpool) Annual Meeting

Contributed Session
A case study method to support and promote recruitment at a multi-centre RCT comparing surgical versus non-surgical treatments

Session Details

Joy Esterlitz
2017 (Liverpool) Annual Meeting

Contributed Session
A Common Data Language for Clinical Research Studies: Five (5) New Disease Recommendations from the National Institute of Neurological Disorders and Stroke, National Institutes of Health Common Data Elements Project

Session Details

Brennan Kahan
2017 (Liverpool) Annual Meeting

Contributed Session
A comparison of adjudication approaches for clinical trials

Session Details

Lesley-Anne Carter
2017 (Liverpool) Annual Meeting

Contributed Session
A comparison of baseline as response and missing indicator methods for missing baseline data in a mixed design cluster randomised control trial

Session Details

Jemma Hudson
2017 (Liverpool) Annual Meeting

Contributed Session
A comparison of methods to handle missing data in the analysis of an area under the curve outcome

Session Details

Ines Rombach
2017 (Liverpool) Annual Meeting

Contributed Session
A comparison of statistical approaches for analysing missing longitudinal patient reported outcome data in randomised controlled trials

Session Details

Peter Godolphin
2017 (Liverpool) Annual Meeting

Contributed Session
A comparison of stroke diagnosis at trial entry by local clinicians versus independent adjudicators: secondary analysis and simulation

Session Details

Marcus Johnson
2017 (Liverpool) Annual Meeting

Contributed Session
A Cross-Cutting Approach to Clinical Trial Success: The US Department of Veterans Affairs’ Network of Dedicated Enrollment Sites (NODES) Model

Session Details

Suzanne Freeman
2017 (Liverpool) Annual Meeting

Contributed Session
A framework for identifying treatment-covariate interactions in individual participant data network meta-analysis

Session Details

Gordon Fernie
2017 (Liverpool) Annual Meeting

Contributed Session
A good use of time and money? A study of how trial data collection effort is distributed across different categories of data.

Session Details

Toby Prevost
2017 (Liverpool) Annual Meeting

Contributed Session
A journey from statistical consultation to funded adaptive trial

Session Details

Iryna Schlackow
2017 (Liverpool) Annual Meeting

Contributed Session
A lifetime disease model based on an RCT: development, validation and applications

Session Details

Pankaj Mistry
2017 (Liverpool) Annual Meeting

Contributed Session
A literature review of the use of Adaptive Design methods in Oncology trials.

Session Details

Derk Arts
2017 (Liverpool) Annual Meeting

Contributed Session
A look at the future of data standardization and sharing in clinical research.

Session Details

Graham Wheeler
2017 (Liverpool) Annual Meeting

Contributed Session
A model-free Bayesian adaptive design for combination therapy dose-finding trials with censored time-to-toxicity data

Session Details

Claire Dyer
2017 (Liverpool) Annual Meeting

Contributed Session
A Multi-Centred Study Validating a Bleeding Assessment Tool (BAT) Developed by the Biomedical Excellence for Safer Transfusion (BEST) Collaborative For Use in Adult Patients with Haematological Malignancy

Session Details

Matteo Quartagno
2017 (Liverpool) Annual Meeting

Contributed Session
A new design for trials for finding optimal treatment duration

Session Details

Emma Wang
2017 (Liverpool) Annual Meeting

Contributed Session
A novel approach to analysis of clinical trials for rare cancers assuming symmetry

Session Details

Hannah Buckley
2017 (Liverpool) Annual Meeting

Contributed Session
A Phase II randomised controlled trial with biomarkers in soft tissue sarcoma: application of a biomarker stratified design

Session Details

Elizabeth Randell
2017 (Liverpool) Annual Meeting

Contributed Session
A pilot randomised controlled trial of community led anti-psychotic drug reduction for adults with learning disabilities: ANDREA-LD

Session Details

Meng Liu
2017 (Liverpool) Annual Meeting

Contributed Session
A predictive probability interim design for phase II clinical trials with continuous endpoints

Session Details

Toshimitsu Hamasaki
2017 (Liverpool) Annual Meeting

Contributed Session
A Program for Training the Next Generation of Biostatisticians in Japan: Developing On-the-Job Training at NCVC

Session Details

Caitlin O'Hara
2017 (Liverpool) Annual Meeting

Contributed Session
A qualitative feasibility study to inform fluids in shock (FiSh) - a pilot randomised controlled trial of fluid bolus therapy in septic shock

Session Details

Caroline Rick
2017 (Liverpool) Annual Meeting

Contributed Session
A reflection on the management of a trial of speech and language therapy.

Session Details

James Howlett
2017 (Liverpool) Annual Meeting

Contributed Session
A Response-Adaptive Trial to Determine the Optimal IL-2 Dose-Frequency to Achieve Multiple Target Increases on Regulatory T Cells in Type 1 Diabetes: DILfrequency study

Session Details

Isabelle Smith
2017 (Liverpool) Annual Meeting

Contributed Session
A review of design and analysis methods for pressure ulcer research

Session Details

Daniel Greenwood
2017 (Liverpool) Annual Meeting

Contributed Session
A review of dose escalation methods in first-in-human small molecule oncology clinical trials

Session Details

Dewen Yang
2017 (Liverpool) Annual Meeting

Contributed Session
A Review of the Essentials and Pitfalls of the Lugano Classification in Malignant Lymphoma Trials

Session Details

Jelena Savovic
2017 (Liverpool) Annual Meeting

Contributed Session
A revised tool for assessing risk of bias in randomized trials (RoB 2.0)

Session Details

Andrew Forbes
2017 (Liverpool) Annual Meeting

Contributed Session
A simple relationship between power and expected confidence interval width

Session Details

Diane Whitham
2017 (Liverpool) Annual Meeting

Contributed Session
A study aimed at improving the conduct and efficiency of trials by developing a standardised set of site performance metrics and a systematic approach to reporting

Session Details

Sophie Betteridge
2017 (Liverpool) Annual Meeting

Contributed Session
A system for real-time integration of laboratory data into trials of targeted therapy with applications to Acute Myeloid Leukaemia

Session Details

Rebecca Barnes
2017 (Liverpool) Annual Meeting

Contributed Session
A systematic mapping review of methods used for the evaluation of implementation fidelity in primary care trials

Session Details

Sena Jawad
2017 (Liverpool) Annual Meeting

Contributed Session
A systematic review identifying neonatal core data elements for clinical trials, and assessment of data completeness of identified data elements using the National Neonatal Research Database (NNRD)

Session Details

Richéal Burns
2017 (Liverpool) Annual Meeting

Contributed Session
A systematic review of analytical methods applied for discarded organs in kidney and liver transplantation research

Session Details

Heather Catt
2017 (Liverpool) Annual Meeting

Contributed Session
A systematic review of core outcomes for Crohn's Disease in adults

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