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.
* 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.
Discover SCT's Scientific Knowledge-Bank
227 Learning Opportunities Found
Chalmers & Green Award Presentations
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Award Presentation
Michael Grayling
Michael Grayling
Alan T. Tita
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Trial of the Year Award
The Chronic Hypertension and Pregnancy Treatment Trial (CHAP)
The Chronic Hypertension and Pregnancy Treatment Trial (CHAP)
Lehana Thabane
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Special Presentation
Annual Business Meeting 2023
Annual Business Meeting 2023
Kirsten Bibbins-Domingo
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Founders Lecture
Medical Publishing in Dynamic Times: A View from JAMA and the JAMA Network
Medical Publishing in Dynamic Times: A View from JAMA and the JAMA Network
Chao Yang
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
An Extended Bayesian Semi-Mechanistic Dose-Finding Design for Phase I Oncology Trials Using Pharmacokinetic and Pharmacodynamic Information
An Extended Bayesian Semi-Mechanistic Dose-Finding Design for Phase I Oncology Trials Using Pharmacokinetic and Pharmacodynamic Information
Sidi Wang
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Dynamical Enrichment of Bayesian Small Sample, Sequential, Multiple Assignment Randomized Trial (snSMART) Design Using Natural History Data: A Case Study From Duchenne Muscular Dystrophy
Dynamical Enrichment of Bayesian Small Sample, Sequential, Multiple Assignment Randomized Trial (snSMART) Design Using Natural History Data: A Case Study From Duchenne Muscular Dystrophy
Xuetao Lu
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Distribution-free Overlapping Indices for Efficient and Robust Information Borrowing in Bayesian Hierarchical Modeling
Distribution-free Overlapping Indices for Efficient and Robust Information Borrowing in Bayesian Hierarchical Modeling
John P.A. Ioannidis
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Curtis Meinert Lecture
Meta-epidemiology of evidence from clinical trials
Meta-epidemiology of evidence from clinical trials
Class of 2023 Fellows
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Fellows Presentation
Valerie Durkalski
Valerie Durkalski
Suzanne Dufault
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
The What and the How: Practical Challenges in Aligning Estimands and Estimation Using Tuberculosis as a Case Study
The What and the How: Practical Challenges in Aligning Estimands and Estimation Using Tuberculosis as a Case Study
Alen Agaronov
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Unproven Interventions During Public Health Crises: The Case of Tecovirimat (TPOXX) for Human Monkey Pox Virus (hMPXV) and the Tension Between Access and Evidence-Generation
Unproven Interventions During Public Health Crises: The Case of Tecovirimat (TPOXX) for Human Monkey Pox Virus (hMPXV) and the Tension Between Access and Evidence-Generation
Lauren Cohen
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Innovations in Pragmatic and Platform Trials using PCORnet®, the National Patient-Centered Clinical Research Network
Innovations in Pragmatic and Platform Trials using PCORnet®, the National Patient-Centered Clinical Research Network
Fan Li
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Advancing Causal Inference Methods for Cluster Randomized Trials
Advancing Causal Inference Methods for Cluster Randomized Trials
Valerie Durkalski-Mauldin
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Statistical Contributions to Risk-Based Monitoring Practices in NIH-funded Clinical Trial Networks
Statistical Contributions to Risk-Based Monitoring Practices in NIH-funded Clinical Trial Networks
Stuart Nicholls
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Examining ethical considerations with patient and public involvement in the design, conduct, analysis, and reporting of clinical trials
Examining ethical considerations with patient and public involvement in the design, conduct, analysis, and reporting of clinical trials
Ashley Vena
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Monitoring Trial Integrity, Study Progress, and Data Quality for Implementation Studies
Monitoring Trial Integrity, Study Progress, and Data Quality for Implementation Studies
John VanBuren
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
A Description of a Collective Team Approach to Risk Based Monitoring
A Description of a Collective Team Approach to Risk Based Monitoring
Shouhao Zhou
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Novel modeling approaches to meta-analysis and data synthesis
Novel modeling approaches to meta-analysis and data synthesis
Michael Miller
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Early Insights from the MoTrPAC Consortium – Uncovering High-Quality Evidence on How Exercise May Optimize Human Health
Early Insights from the MoTrPAC Consortium – Uncovering High-Quality Evidence on How Exercise May Optimize Human Health
Jeannette Lee
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
The IDeA States Pediatric Clinical Trials Network: Reaching Children in Rural and Underserved Populations
The IDeA States Pediatric Clinical Trials Network: Reaching Children in Rural and Underserved Populations
Laura Levit
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Optimizing Dose Selection Strategies in Oncology
Optimizing Dose Selection Strategies in Oncology
Lu Mao
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Addressing challenges of nonstandard time-to-event endpoints in clinical trials
Addressing challenges of nonstandard time-to-event endpoints in clinical trials
Martin Offringa
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
New SPIRIT & CONSORT Extensions to Trial Outcomes: Development, Implementation, & Challenges for Authors and Journals
New SPIRIT & CONSORT Extensions to Trial Outcomes: Development, Implementation, & Challenges for Authors and Journals
Dixie Ecklund
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Increasing Demographic Representation of Participants in NIH HEAL-funded studies: Experiences from the Acute to Chronic Pain Signatures (A2CPS) Program, BackinAction (BIA) New York, Diversity in Clinical Trial (DCTR) Study, and Ketamine Analgesia for Long-lasting Pain relief After Surgery (KALPAS) Study
Increasing Demographic Representation of Participants in NIH HEAL-funded studies: Experiences from the Acute to Chronic Pain Signatures (A2CPS) Program, BackinAction (BIA) New York, Diversity in Clinical Trial (DCTR) Study, and Ketamine Analgesia for Long-lasting Pain relief After Surgery (KALPAS) Study
Chenguang Wang
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Statistical considerations in constructing estimands for clinical trial design and analysis: Addressing issues beyond intercurrent events
Statistical considerations in constructing estimands for clinical trial design and analysis: Addressing issues beyond intercurrent events
Anna Snavely
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Design and statistical considerations for cluster randomized trials in community settings: Lessons from across the NCI Community Oncology Research Program (NCORP)
Design and statistical considerations for cluster randomized trials in community settings: Lessons from across the NCI Community Oncology Research Program (NCORP)
Gerard Slobogean
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Challenges and Opportunities for Patient Engagement and Novel Study Designs in Pragmatic Trials and Comparative Effectiveness Research
Challenges and Opportunities for Patient Engagement and Novel Study Designs in Pragmatic Trials and Comparative Effectiveness Research
Marion Campbell
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
When and how to evaluate innovative and evolving healthcare technology
When and how to evaluate innovative and evolving healthcare technology
Kert Viele
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Bringing Balance to Response Adaptive Randomization
Bringing Balance to Response Adaptive Randomization
Hajime Uno
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Statistical Challenges in Pragmatic Stepped-Wedge Cluster Randomized Trials: Three Case Studies from the Improving the Management of Symptoms during and following Cancer Treatment Consortium
Statistical Challenges in Pragmatic Stepped-Wedge Cluster Randomized Trials: Three Case Studies from the Improving the Management of Symptoms during and following Cancer Treatment Consortium
Dario Gregori
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A Bayesian Approach to the Design of Cathlab-Base Intervention Trials: The Case of SAFE-IN-BIOSS Study
A Bayesian Approach to the Design of Cathlab-Base Intervention Trials: The Case of SAFE-IN-BIOSS Study
Jacqueline Thompson
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A comparison of methods for estimating adjusted dichotomous treatment effects: a simulation evaluation
A comparison of methods for estimating adjusted dichotomous treatment effects: a simulation evaluation
Ruqayya Azher
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A comparison of randomisation methods for multi-arm clinical trials
A comparison of randomisation methods for multi-arm clinical trials
Navneet Hakhu
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A Comparison of Statistical Methods for Evaluation of Slope-based Estimated Glomerular Filtration Rate in Chronic Kidney Disease Randomized Controlled Clinical Trials
A Comparison of Statistical Methods for Evaluation of Slope-based Estimated Glomerular Filtration Rate in Chronic Kidney Disease Randomized Controlled Clinical Trials
Corinne McGill
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A Data Coordinating Center’s Role in Risk Factor Management
A Data Coordinating Center’s Role in Risk Factor Management
Samuel Sarkodie
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A hybrid approach to sample size reestimation in cluster randomized trials with continuous outcome
A hybrid approach to sample size reestimation in cluster randomized trials with continuous outcome
Fei Yuan
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A long-term cost-utility analysis of low-dose pioglitazone versus placebo on a population with prediabetes and a history of stroke and transient ischemic attack: A Canadian perspective
A long-term cost-utility analysis of low-dose pioglitazone versus placebo on a population with prediabetes and a history of stroke and transient ischemic attack: A Canadian perspective
Raymond Cha
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A Medication Interaction Categorization Resource for Clinical Trial Development and Conduct
A Medication Interaction Categorization Resource for Clinical Trial Development and Conduct
Saskia Eddy
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A methodological systematic review of sample size justifications for external randomised controlled pilot trials
A methodological systematic review of sample size justifications for external randomised controlled pilot trials
Clement Ma
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A novel application of umbrella designs in multi-domain dementia prevention
A novel application of umbrella designs in multi-domain dementia prevention
Kat Asman
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A Novel Approach to Harmonizing Site Locations for a Network of Networks
A Novel Approach to Harmonizing Site Locations for a Network of Networks
Munya Dimairo
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A Practical Adaptive Designs Toolkit: Making adaptive designs more accessible
A Practical Adaptive Designs Toolkit: Making adaptive designs more accessible
Xueting Wang
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A robust Bayesian model averaging method for basket trials with different endpoints
A robust Bayesian model averaging method for basket trials with different endpoints
Xinyu Xue
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A scoping review on the methodological and reporting quality of scoping reviews in China
A scoping review on the methodological and reporting quality of scoping reviews in China
Roger Lewis
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Educational Session
A Statistical Editor’s Perspective on the Review and Reporting of Results from Randomized Clinical Trials
A Statistical Editor’s Perspective on the Review and Reporting of Results from Randomized Clinical Trials
Jacqueline Thompson
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A systematic review of simulation studies evaluating dichotomous outcomes within the biomedical research literature
A systematic review of simulation studies evaluating dichotomous outcomes within the biomedical research literature
Lijuan Zeng
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A tool for assessing benefit:risk and equipoise for monitoring clinical trials
A tool for assessing benefit:risk and equipoise for monitoring clinical trials
Luke Ouma
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
A two-stage Bayesian adaptive umbrella design borrowing information over the control data
A two-stage Bayesian adaptive umbrella design borrowing information over the control data
Matthew Sydes
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Academic-led trials for regulatory use
Academic-led trials for regulatory use
Lauren Yesko
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Adapting the Agile Practice of Retrospectives for Clinical Trial Management
Adapting the Agile Practice of Retrospectives for Clinical Trial Management
Sean Ewings
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Adapting to Adaptive Designs: Guidance for Delivering Complex Phase I Trials
Adapting to Adaptive Designs: Guidance for Delivering Complex Phase I Trials
Taylor Phillips
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Addressing Challenges of Lab Data Collection and Automation in Lung-MAP
Addressing Challenges of Lab Data Collection and Automation in Lung-MAP
Letitia Perdue
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Alert System for the PREVENTABLE trial
Alert System for the PREVENTABLE trial
Aritra Mukherjee
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
An evaluation of Impact of outcome delay on Multi-stage Group Sequential Trials
An evaluation of Impact of outcome delay on Multi-stage Group Sequential Trials
Wenle Zhao
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Application of Artificial Intelligence in Study Supply Logistics Management for Large Multicenter Clinical Trials
Application of Artificial Intelligence in Study Supply Logistics Management for Large Multicenter Clinical Trials
RANI JAYSWAL
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Application of Interim Monitoring Strategies for Targeted and Precision Medicine Clinical Trials
Application of Interim Monitoring Strategies for Targeted and Precision Medicine Clinical Trials
Theodore Karrison
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Application of Royston and Parmar's Flexible Parametric Survival Model to Interval-Censored Data
Application of Royston and Parmar's Flexible Parametric Survival Model to Interval-Censored Data
Saskia Eddy
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Appropriate Sample Size for External Randomised Controlled Pilot Trials: Results from a Modified Delphi Study
Appropriate Sample Size for External Randomised Controlled Pilot Trials: Results from a Modified Delphi Study
Edward Mascha
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Average relative effect tests for binary, count and survival composite outcomes: multivariate methods in rescue of the less frequent components.
Average relative effect tests for binary, count and survival composite outcomes: multivariate methods in rescue of the less frequent components.
Lou Whitehead
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Bayesian borrowing for basket trials with longitudinal outcomes
Bayesian borrowing for basket trials with longitudinal outcomes
Joe Marion
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Bayesian Borrowing of Phase II Data: Case Study from the PUNCH CD3 Trial
Bayesian Borrowing of Phase II Data: Case Study from the PUNCH CD3 Trial
Jonathan Beall
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Bayesian Enrollment Modeling for Several Emergency Medicine Clinical Trials
Bayesian Enrollment Modeling for Several Emergency Medicine Clinical Trials
Chaoqun Mei
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Bayesian Model Averaging Bayesian Logistic Regression Model with Overdose Control in Phase I Dose-Escalation Clinical Trials
Bayesian Model Averaging Bayesian Logistic Regression Model with Overdose Control in Phase I Dose-Escalation Clinical Trials
Jonathan Beall
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Bayesian Predictive Probabilities After Multiple Imputation
Bayesian Predictive Probabilities After Multiple Imputation
Danni Shi
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Behavioral Carry-Over Effect and Power Consideration in Crossover Trials
Behavioral Carry-Over Effect and Power Consideration in Crossover Trials
Katie Gillies
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Behavioural Optimisation & Operational Strategies for Trials: The BOOST Approach
Behavioural Optimisation & Operational Strategies for Trials: The BOOST Approach
Lizhao Ge
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Benefit-risk assessments during a clinical trial using Desirability of Outcome Ranking (DOOR) methodology: A prediction approach
Benefit-risk assessments during a clinical trial using Desirability of Outcome Ranking (DOOR) methodology: A prediction approach
Eve Jelstrom
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Best Practices for Establishing a Clinical Trial Agreement for Study Medication Donation
Best Practices for Establishing a Clinical Trial Agreement for Study Medication Donation
Ludovic Trinquart
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Beware the hazard ratio: a case of pluralistic ignorance?
Beware the hazard ratio: a case of pluralistic ignorance?
Chris Cook
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Beyond Static Tables and Figures: Utilizing Technology to Make Tables and Figures Richer and More Interactive
Beyond Static Tables and Figures: Utilizing Technology to Make Tables and Figures Richer and More Interactive
Su Jin Kang
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Biostatical Models to Investigate Physiological Mediators regarding Cognition on Cardio-Metabolic Risk Factors in the Middle-Aged: the CARDIA Study
Biostatical Models to Investigate Physiological Mediators regarding Cognition on Cardio-Metabolic Risk Factors in the Middle-Aged: the CARDIA Study
Joe Marion
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Borrowing Phase II data in Phase III: the PUNCH CD3 Case Study.
Borrowing Phase II data in Phase III: the PUNCH CD3 Case Study.
Jennifer Hagar
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Calibration of the NeuroNEXT Network Per-Participant Fee (PPF) Schedule to Align with Clinical Study Site Costs
Calibration of the NeuroNEXT Network Per-Participant Fee (PPF) Schedule to Align with Clinical Study Site Costs
Lauren Bradley
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Clinical Site Monitoring in the Time of COVID-19: Best Practices in Remote Monitoring on the Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW) Trials
Clinical Site Monitoring in the Time of COVID-19: Best Practices in Remote Monitoring on the Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW) Trials
Douglas Jabs
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Clinical trial outcomes for a single treatment used across multiple uncommon uveitic diseases: The ADVISE Trial
Clinical trial outcomes for a single treatment used across multiple uncommon uveitic diseases: The ADVISE Trial
Joel Horovitz
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Educational Session
Clinical Trials for Surgical Intervention and Devices: what is IDEAL?
Clinical Trials for Surgical Intervention and Devices: what is IDEAL?
Lauren Dresser
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Co-Enrollment Within the National Drug Abuse Treatment Clinical Trials Network: Operational Considerations and Strategies for Success
Co-Enrollment Within the National Drug Abuse Treatment Clinical Trials Network: Operational Considerations and Strategies for Success
Brittany Ober Shepherd
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Cohort Development at Unprecedented Speed: Lessons from a Next-Generation SARS-CoV-2 Vaccine Trial
Cohort Development at Unprecedented Speed: Lessons from a Next-Generation SARS-CoV-2 Vaccine Trial
Dinh Tran
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Compare Clinical Outcomes between Dual Arterial Grafts and Single Arterial Graft Coronary Artery Bypass Surgery: A Natural Experimental Approach.
Compare Clinical Outcomes between Dual Arterial Grafts and Single Arterial Graft Coronary Artery Bypass Surgery: A Natural Experimental Approach.
Alina (Hyolim) Lee
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Comparing analytical strategies for balancing site-level characteristics in stepped-wedge cluster randomized trials: a simulation study
Comparing analytical strategies for balancing site-level characteristics in stepped-wedge cluster randomized trials: a simulation study
Yifan (Katie) Wang
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Confidence Interval Estimation and Sample Size Calculation in Comparative Use Human Factors (CUHF) Study
Confidence Interval Estimation and Sample Size Calculation in Comparative Use Human Factors (CUHF) Study
Danielle Cunio
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Contacting Difficult To Reach Participants: The Systolic Blood Pressure Intervention Trial Mind 2020
Contacting Difficult To Reach Participants: The Systolic Blood Pressure Intervention Trial Mind 2020
Hakim-Moulay Dehbi
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Controlled amplification in oncology dose-finding trials
Controlled amplification in oncology dose-finding trials
Chia-Rui (Jerry) Chang
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Covariate Adjustment in Randomized Experiments with Incomplete Baseline Data
Covariate Adjustment in Randomized Experiments with Incomplete Baseline Data
Zhongying Xu
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Covariate-adjusted Response Adaptive Randomization with a Composite Endpoint of Mortality and Morbidity
Covariate-adjusted Response Adaptive Randomization with a Composite Endpoint of Mortality and Morbidity
Maria Vittoria Chiaruttini
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Coverage probability assessment for a three-arm noninferiority trial design for health care cost data: a simulation study
Coverage probability assessment for a three-arm noninferiority trial design for health care cost data: a simulation study
Anusha Yarava
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Creating a Blood Bank Coordinating Center for Inventory Management & Accountability in COVID-19 Clinical Trials
Creating a Blood Bank Coordinating Center for Inventory Management & Accountability in COVID-19 Clinical Trials
Jessica Anderson
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Curating High-quality Data and Reporting for Human Health Research with Limited Resources
Curating High-quality Data and Reporting for Human Health Research with Limited Resources
Kara-Louise Royle
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Current practice and opinions on the analysis of overall survival and subsequent treatment lines in cancer clinical trials: a systematic review and online questionnaire
Current practice and opinions on the analysis of overall survival and subsequent treatment lines in cancer clinical trials: a systematic review and online questionnaire
Lin Nan
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Data Management of Remote Spirometry in a Telehealthcare Trial
Data Management of Remote Spirometry in a Telehealthcare Trial
Azzolina Danila
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Dealing with intercurrent events occurrence and subsequent confounding in pediatric RCT via propensity score estimation methods
Dealing with intercurrent events occurrence and subsequent confounding in pediatric RCT via propensity score estimation methods
Liam Bishop
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Dermatology trial design considerations to improve diversity and inclusion of patients from ethnic minority backgrounds
Dermatology trial design considerations to improve diversity and inclusion of patients from ethnic minority backgrounds
Herbert Pang
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Educational Session
Design and Analysis of Randomized Clinical Trials with Real-World Data
Design and Analysis of Randomized Clinical Trials with Real-World Data
Luke Ouma
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Design and analysis of umbrella trials: where do we stand?
Design and analysis of umbrella trials: where do we stand?
Kaleab Abebe
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Design and rationale of a patient-centered, randomized trial of a process-of-care intervention in hospitalized AKI patients: the COPE-AKI Trial
Design and rationale of a patient-centered, randomized trial of a process-of-care intervention in hospitalized AKI patients: the COPE-AKI Trial
Shanshan Zhang
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Designing Clinical Trials with Clinical and Stewardship Outcomes as Co-primary Endpoints using Desirability of Outcome Ranking Methodology
Designing Clinical Trials with Clinical and Stewardship Outcomes as Co-primary Endpoints using Desirability of Outcome Ranking Methodology
Chengjie Xiong
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Designing Secondary Prevention Trials of Alzheimer Disease by Accounting for Racial Differences in Alzheimer Disease Biomarkers
Designing Secondary Prevention Trials of Alzheimer Disease by Accounting for Racial Differences in Alzheimer Disease Biomarkers
Kendra Plourde
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Designing Stepped Wedge Cluster Randomized Trials with a Baseline Measurement of the Outcome
Designing Stepped Wedge Cluster Randomized Trials with a Baseline Measurement of the Outcome
Christina Yap
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Developing International Consensus-Driven SPIRIT and CONSORT Extensions for Early Phase Dose-Finding Clinical Trials: the DEFINE (DosE FIndiNg Extensions) Study
Developing International Consensus-Driven SPIRIT and CONSORT Extensions for Early Phase Dose-Finding Clinical Trials: the DEFINE (DosE FIndiNg Extensions) Study
William Cragg
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Developing Principles for a Comprehensive, Modernised Approach to Managing Clinical Trial Participation Changes through the UK Clinical Research Collaboration Registered Clinical Trials Unit Network’s PeRSEVERE Project
Developing Principles for a Comprehensive, Modernised Approach to Managing Clinical Trial Participation Changes through the UK Clinical Research Collaboration Registered Clinical Trials Unit Network’s PeRSEVERE Project
Juan Vintimilla
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
DMC members’ views on their role in ensuring representation and inclusivity in clinical trials
DMC members’ views on their role in ensuring representation and inclusivity in clinical trials
Zhulin Yin
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Dose transition pathways for Time-to-event Continual Reassessment Method: will imposing a waiting time result in better performance?
Dose transition pathways for Time-to-event Continual Reassessment Method: will imposing a waiting time result in better performance?
Emily Rives
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Drug Tracking and Distribution of a Controlled Substance in the LEAP Trial
Drug Tracking and Distribution of a Controlled Substance in the LEAP Trial
Michael Terrin
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Effect of Interim Analysis Monitoring for Secondary Outcomes on Unconditional Statistical Power
Effect of Interim Analysis Monitoring for Secondary Outcomes on Unconditional Statistical Power
Benjamin Carlisle
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Effect Size Shrinkage and False Positivity in Immune Checkpoint Inhibitor Drug FDA Approvals: Methods and preliminary results for a large drug trial portfolio analysis
Effect Size Shrinkage and False Positivity in Immune Checkpoint Inhibitor Drug FDA Approvals: Methods and preliminary results for a large drug trial portfolio analysis
Brett Hart
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Effectiveness of a Dedicated Tracking Tool for Ensuring Timely, High-Quality Documentation of Study Participant Mental Health Follow-Up
Effectiveness of a Dedicated Tracking Tool for Ensuring Timely, High-Quality Documentation of Study Participant Mental Health Follow-Up
Maria Vittoria Chiaruttini
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Effects of vitamin D combined with oral iron supplementation in patients with chronic heart failure and iron deficiency (VICTORID-HF TRIAL): statistical design
Effects of vitamin D combined with oral iron supplementation in patients with chronic heart failure and iron deficiency (VICTORID-HF TRIAL): statistical design
Yudong Huang
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Enhancing Efficiency and Quality of Study Database Development by Using Case Report Form Templates
Enhancing Efficiency and Quality of Study Database Development by Using Case Report Form Templates
Ted Lystig
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Session Proposal
Enhancing the Efficiency of Conducting Clinical Trials: Lessons from the COVID-19 Pandemic
Enhancing the Efficiency of Conducting Clinical Trials: Lessons from the COVID-19 Pandemic
Julissa Almonte Santana
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Ensuring Data Quality for Lipid Samples through Shipping Manifest Creation and Data Transfer Discrepancies Review
Ensuring Data Quality for Lipid Samples through Shipping Manifest Creation and Data Transfer Discrepancies Review
Mitra Lewis
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Ensuring High-Quality Data Through Tracking and Resolution of Action Items in Multisite Clinical Trials
Ensuring High-Quality Data Through Tracking and Resolution of Action Items in Multisite Clinical Trials
Nafis Neehal
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
EquiSCAT: Strategies for Equity Considerations in Synthetic Control Arm Design
EquiSCAT: Strategies for Equity Considerations in Synthetic Control Arm Design
Pauline Wipfler
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Establishing the VACCELERATE Site Network: Capacity Mapping of Clinical Trial Sites
Establishing the VACCELERATE Site Network: Capacity Mapping of Clinical Trial Sites
Matteo Quartagno
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Estimation of Restricted Mean Survival Time under proportional hazards in Non-Inferiority trials
Estimation of Restricted Mean Survival Time under proportional hazards in Non-Inferiority trials
Azzolina Danila
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Ethnic minority participation in advanced clinical trial design: a ClinicalTrial.gov review
Ethnic minority participation in advanced clinical trial design: a ClinicalTrial.gov review
Anna Moseley
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Evaluating the impact of stratification, sample size, and randomization ratio on the power of randomized Phase 2 clinical trials
Evaluating the impact of stratification, sample size, and randomization ratio on the power of randomized Phase 2 clinical trials
Stuart Nicholls
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Evaluation of a verbal consent approach to research in the emergency room: the RAFF4 sub study
Evaluation of a verbal consent approach to research in the emergency room: the RAFF4 sub study
Megan McCabe
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Evaluation of Current Practices in the Reporting of Results from Platform Trials
Evaluation of Current Practices in the Reporting of Results from Platform Trials
Jessica Capaldi
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Examining the recruitment strategies and feasibility of a virtual peer-based physical activity intervention for underserved adolescent and young adult cancer survivors
Examining the recruitment strategies and feasibility of a virtual peer-based physical activity intervention for underserved adolescent and young adult cancer survivors
Laura Ross
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Extensive Data and Consistency Checks Used to Ensure High Quality Data in a Multi-Site/Country Phase 3 Breast Cancer Study (OlympiA) with two Distinct Data Capture Systems
Extensive Data and Consistency Checks Used to Ensure High Quality Data in a Multi-Site/Country Phase 3 Breast Cancer Study (OlympiA) with two Distinct Data Capture Systems
Jun Yin
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
External Control Designs to Incorporate Real-world Evidence with Adaptive Information Borrowing
External Control Designs to Incorporate Real-world Evidence with Adaptive Information Borrowing
Shelby Roberts
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Facilitating Strategic Operational Readiness for Master Protocols
Facilitating Strategic Operational Readiness for Master Protocols
Jennifer Gassman
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Facilitating Submission of Results to ClinicalTrials.gov
Facilitating Submission of Results to ClinicalTrials.gov
Joseph Rigdon
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Flexible Detection of Participant and Site Outliers in Multisite Clinical Trials
Flexible Detection of Participant and Site Outliers in Multisite Clinical Trials
Connor Keegan
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Gaining Covid’s Consent: eConsent
Gaining Covid’s Consent: eConsent
Guoqing Diao
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Group sequential designs for clustered data in randomized eye trials
Group sequential designs for clustered data in randomized eye trials
Tracy Bergemann
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Group Sequential Designs with a Win-ratio Statistic
Group Sequential Designs with a Win-ratio Statistic
Jean-Christopher Arnaud
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Handling Files with Protected Health Information in Multicenter Clinical Trials
Handling Files with Protected Health Information in Multicenter Clinical Trials
Katie Gillies
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Have you tried turning it off, and back on again?: Running trials involving digital home monitoring technologies - lessons from the I-TRAC feasibility Study.
Have you tried turning it off, and back on again?: Running trials involving digital home monitoring technologies - lessons from the I-TRAC feasibility Study.
Charlotte Ouimet
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
How Many Patients Does It Take to Repurpose a Cancer Drug? A Retrospective Cohort Study of Post-approval Oncology Drugs
How Many Patients Does It Take to Repurpose a Cancer Drug? A Retrospective Cohort Study of Post-approval Oncology Drugs
Kevin Venner
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
How to Detect Risks of Partial Unblinding for Kit Type Differences within Clinical Trials
How to Detect Risks of Partial Unblinding for Kit Type Differences within Clinical Trials
Laura Morrison
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
How to prepare for an Application Orientation Meeting (AOM) with the FDA
How to prepare for an Application Orientation Meeting (AOM) with the FDA
Jose-Miguel Yamal
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
If an outcome assessment is missed, can the study still accurately collect this outcome at a later point of time?
If an outcome assessment is missed, can the study still accurately collect this outcome at a later point of time?
Arinjita Bhattacharyya
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Educational Session
Immunotherapy, Dose Escalation, Master Protocols and Personalized Medicine in Oncology Clinical Trials
Immunotherapy, Dose Escalation, Master Protocols and Personalized Medicine in Oncology Clinical Trials
Logan William
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Implementation of a Sustainable Network Structure: Examining the Last 10 Years in StrokeNet
Implementation of a Sustainable Network Structure: Examining the Last 10 Years in StrokeNet
Wenle Zhao
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Educational Session
Implementation of advanced subject randomization algorithms in complex clinical trials
Implementation of advanced subject randomization algorithms in complex clinical trials
Rayka Malek
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Implementation of MAMS seamless phase 2-3 design in vitamin supplements trial
Implementation of MAMS seamless phase 2-3 design in vitamin supplements trial
Amber Hopmann
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Implementing a Collaborative Project Schedule to Increase Communication and Efficiency in Clinical Trial Management
Implementing a Collaborative Project Schedule to Increase Communication and Efficiency in Clinical Trial Management
Shun Fu Lee
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Improving analysis of cognitive outcomes in cardiovascular trials using different statistical approaches
Improving analysis of cognitive outcomes in cardiovascular trials using different statistical approaches
Eve Walter
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Improving Racial and Ethnic Diversity in Clinical Trials
Improving Racial and Ethnic Diversity in Clinical Trials
Gail Potter
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Incorporating genotyping data into malaria vaccine efficacy estimates to improve trial efficiency
Incorporating genotyping data into malaria vaccine efficacy estimates to improve trial efficiency
Marion Kerioui
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Information-borrowing designs for phase II clinical trials with multiple patient subgroups
Information-borrowing designs for phase II clinical trials with multiple patient subgroups
David Beard
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Interpreting chaos: a priori account of expected variation in treatment compliance and fidelity
Interpreting chaos: a priori account of expected variation in treatment compliance and fidelity
Yunxuan Zhang
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Inverse propensity score weighted multisource exchangeability models for incorporating external data in randomized clinical trials
Inverse propensity score weighted multisource exchangeability models for incorporating external data in randomized clinical trials
Beatriz Goulão
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Involving patients and the public In sTatistIcal Analysis pLans (INITIAL): A delphi survey
Involving patients and the public In sTatistIcal Analysis pLans (INITIAL): A delphi survey
Bryan Simmons
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Lessons in methodology from a large, stepped-wedge study in a low-accessibility, understudied population
Lessons in methodology from a large, stepped-wedge study in a low-accessibility, understudied population
Ying Yuan
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Educational Session
Leveraging external data through Bayesian methods in clinical trials
Leveraging external data through Bayesian methods in clinical trials
Shiyu Shu
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Longitudinal benefit:risk analysis through desirability of outcome ranking (DOOR)
Longitudinal benefit:risk analysis through desirability of outcome ranking (DOOR)
Mary Putt
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Managing covariate imbalance in a matched-pair cluster randomized trial: Interpretation and performance of calibration versus individual-level methodologies with application to an HIV prevention study.
Managing covariate imbalance in a matched-pair cluster randomized trial: Interpretation and performance of calibration versus individual-level methodologies with application to an HIV prevention study.
Thenmalar Vadiveloo
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Maximising power for patient reported outcomes with ceiling or floor effects.
Maximising power for patient reported outcomes with ceiling or floor effects.
Ayoola Ademola
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Meta-analytic models for synthesizing evidence from explanatory and pragmatic trials
Meta-analytic models for synthesizing evidence from explanatory and pragmatic trials
Brennan Kahan
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Methodology and Results of the CONSORT and SPIRIT Extensions for Factorial Trials
Methodology and Results of the CONSORT and SPIRIT Extensions for Factorial Trials
Jennifer Ross
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Monitoring of Flexible Randomization Schemes in Master Protocols
Monitoring of Flexible Randomization Schemes in Master Protocols
Meredith McCormack-Mager
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Moving Students: How Transfer Students Affect Power and Type I Error in Stepped Wedge Designs
Moving Students: How Transfer Students Affect Power and Type I Error in Stepped Wedge Designs
Milo Puhan
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Natural course of post COVID-19 condition and implications for trial design and outcome selection
Natural course of post COVID-19 condition and implications for trial design and outcome selection
Jessica Overbey
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Non-Ignorable Missing Intravascular Ultrasound Data – Lessons from the VEST Trial
Non-Ignorable Missing Intravascular Ultrasound Data – Lessons from the VEST Trial
Zhibao Mi
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Non-parametric Inference after Multiple Imputation of Missing Data in Clinical Trials
Non-parametric Inference after Multiple Imputation of Missing Data in Clinical Trials
Xuezhou Mao
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
On the Confidence Interval Construction for Relative Risk Endpoint of Super-Superiority Vaccine Efficacy Trials in Infectious Diseases
On the Confidence Interval Construction for Relative Risk Endpoint of Super-Superiority Vaccine Efficacy Trials in Infectious Diseases
Sheila Sprague
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Opportunities to Improve Participant Experience in Clinical Research: Implications of a Pragmatic Design and Inclusion of Patient-Partner Representatives
Opportunities to Improve Participant Experience in Clinical Research: Implications of a Pragmatic Design and Inclusion of Patient-Partner Representatives
Laura Etfer
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Optimal Allocation of Clusters to Sequences in Stepped Wedge Trials with Binary Outcome Data
Optimal Allocation of Clusters to Sequences in Stepped Wedge Trials with Binary Outcome Data
Emily Alger
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Optimising participant flow diagrams for Phase I clinical trials
Optimising participant flow diagrams for Phase I clinical trials
Babak Choodari-Oskooei
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Optimizing multi-arm multi-stage platform randomised clinical trials in the phase III setting: with applications to the ROSSINI 2 (surgical) trial
Optimizing multi-arm multi-stage platform randomised clinical trials in the phase III setting: with applications to the ROSSINI 2 (surgical) trial
William Cragg
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Patient-Researcher Collaboration to Guide the Provision of Information to Support Clinical Trial Participants Who Stop Taking Part Early
Patient-Researcher Collaboration to Guide the Provision of Information to Support Clinical Trial Participants Who Stop Taking Part Early
Justin Clapp
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Physician Gatekeeping in Pragmatic Trials: A Qualitative Study of Clinical Reasoning about Patient Randomization
Physician Gatekeeping in Pragmatic Trials: A Qualitative Study of Clinical Reasoning about Patient Randomization
Michael Grayling
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Point estimation after a two-stage single-arm trial monitoring toxicity and efficacy
Point estimation after a two-stage single-arm trial monitoring toxicity and efficacy
Mary Ryan
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Power Calculation for Cross-Sectional Stepped Wedge Cluster Randomized Trials with a Time-to-Event Endpoint
Power Calculation for Cross-Sectional Stepped Wedge Cluster Randomized Trials with a Time-to-Event Endpoint
Gene Pennello
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Pragmatic trials of medical testing strategies
Pragmatic trials of medical testing strategies
Emily Woolley
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Preserving Trial Integrity after Receiving an Unanticipated Data Monitoring Committee (DMC) Recommendation
Preserving Trial Integrity after Receiving an Unanticipated Data Monitoring Committee (DMC) Recommendation
Azzolina Danila
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Profiling non-inferiority assessment in RCT via SuperLearner estimation approach: a simulation study and application to Dubius trial.
Profiling non-inferiority assessment in RCT via SuperLearner estimation approach: a simulation study and application to Dubius trial.
Karina Kapitanovsky
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Protocol Deviation System for the PREVENTABLE trial
Protocol Deviation System for the PREVENTABLE trial
Sarah Leatherman
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Provider Experiences and Attitudes in an Embedded Pragmatic Clinical Trial
Provider Experiences and Attitudes in an Embedded Pragmatic Clinical Trial
Phoebe Gauthier
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Providing a Pre-Paid Cell Phone as Incentive for Research Participation: Recruitment Strategy from a Multi-Site Emergency Department Study During the COVID-19 Pandemic
Providing a Pre-Paid Cell Phone as Incentive for Research Participation: Recruitment Strategy from a Multi-Site Emergency Department Study During the COVID-19 Pandemic
Phyllis Goodman
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Quality Metrics in a National Clinical Trial Network Group
Quality Metrics in a National Clinical Trial Network Group
Tolu Sajobi
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Quality of Life Outcomes in Acute Stroke Trials: Same questions, but different meaning to different patients
Quality of Life Outcomes in Acute Stroke Trials: Same questions, but different meaning to different patients
Bareng Aletta Nonyane
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Randomization in multi-arm cluster randomized trials: balance and validity considerations
Randomization in multi-arm cluster randomized trials: balance and validity considerations
Yi Chen
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Randomized Phase II Selection Design with Order Constrained Strata
Randomized Phase II Selection Design with Order Constrained Strata
Emine Bayman
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Re-assessing the Sample Size in a Cluster Randomized Trial
Re-assessing the Sample Size in a Cluster Randomized Trial
Xiangji Ying
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Re-Evaluating Role of Pilot Trials to Inform Key Parameters of Larger Trials: A Meta-Epidemiological Study
Re-Evaluating Role of Pilot Trials to Inform Key Parameters of Larger Trials: A Meta-Epidemiological Study
Brian Alper
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Reporting Study Design with the Scientific Evidence Code System (SEVCO): A Novel Community-reviewed Standard Vocabulary
Reporting Study Design with the Scientific Evidence Code System (SEVCO): A Novel Community-reviewed Standard Vocabulary
Yulia Marchenko
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Educational Session
Reproducibility and automated reporting in clinical trials
Reproducibility and automated reporting in clinical trials
Janet Holbrook
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Responding to Emerging Safety Signal in Trials of Approved Drugs for New Indications – Safety Monitoring for the Losartan for Effects on Emphysema Progression (LEEP) Trial
Responding to Emerging Safety Signal in Trials of Approved Drugs for New Indications – Safety Monitoring for the Losartan for Effects on Emphysema Progression (LEEP) Trial
Ludovic Trinquart
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Educational Session
Restricted mean survival times for the design and analysis of clinical trials and their meta-analyses
Restricted mean survival times for the design and analysis of clinical trials and their meta-analyses
Nicholas Medhurst
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Rethinking the Principles: Good RCT Design, Conduct, Reporting and Regulation
Rethinking the Principles: Good RCT Design, Conduct, Reporting and Regulation
Fang-Shu Ou
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Robustness of the MaxCombo Test under Model Miss-specification
Robustness of the MaxCombo Test under Model Miss-specification
J Athene Lane
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
ROUTINELY COLLECTED OUTCOME DATA FOR A MORE EFFICIENT APPROACH TO CLUSTER RANDOMISED CONTROLLED TRIALS IN PRIMARY CARE
ROUTINELY COLLECTED OUTCOME DATA FOR A MORE EFFICIENT APPROACH TO CLUSTER RANDOMISED CONTROLLED TRIALS IN PRIMARY CARE
Xueqi Wang
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Sample size calculation for detecting interaction effects in 2-period cluster randomized crossover designs with unequal cluster sizes
Sample size calculation for detecting interaction effects in 2-period cluster randomized crossover designs with unequal cluster sizes
Guangyu Tong
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Sample size considerations for assessing treatment effect heterogeneity in randomized trials with heterogeneous intracluster correlations and variances
Sample size considerations for assessing treatment effect heterogeneity in randomized trials with heterogeneous intracluster correlations and variances
Lara Maleyeff
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Sample size determination for testing treatment effect heterogeneity in cluster randomized trials with binary outcomes
Sample size determination for testing treatment effect heterogeneity in cluster randomized trials with binary outcomes
Annastazia Learoyd
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Sample size issues in a real word example of a Cluster Randomised Superiority Trial
Sample size issues in a real word example of a Cluster Randomised Superiority Trial
Maria Vittoria Chiaruttini
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Sample size re-estimation in a non-inferiority trial for healthcare cost data
Sample size re-estimation in a non-inferiority trial for healthcare cost data
Juliet High
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Screening Log Guidelines (SLoG): A Standardised Model for Screening Data: Who Should Be Included and Which Data Should Be Collected?
Screening Log Guidelines (SLoG): A Standardised Model for Screening Data: Who Should Be Included and Which Data Should Be Collected?
Xiaoyan Yin Yin
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Sequential Multiple Assignment Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART-COMPASS): Design and Software
Sequential Multiple Assignment Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART-COMPASS): Design and Software
Elizabeth Colantuoni
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Shifting landscape of composite endpoints in trials conducted among seriously and critically ill patients
Shifting landscape of composite endpoints in trials conducted among seriously and critically ill patients
Loretta Davies
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Shifting the balance: optimising the design and delivery of trials with diverse comparisons
Shifting the balance: optimising the design and delivery of trials with diverse comparisons
Mengfen Wu
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Standardizing the dose escalation report in phase I dose-escalation trials
Standardizing the dose escalation report in phase I dose-escalation trials
Babak Choodari-Oskooei
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Educational Session
Statistical and practical aspects of the design and analysis of Multi-Arm Multi-Stage (MAMS) Platform Trials
Statistical and practical aspects of the design and analysis of Multi-Arm Multi-Stage (MAMS) Platform Trials
Francesca Fiorentino
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Statistical methods for handling compliance in randomised controlled trials of device interventions: a systematic review.
Statistical methods for handling compliance in randomised controlled trials of device interventions: a systematic review.
KaShawna Guy
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Strategies for Efficiently Building Public Facing Websites to Promote Participant Recruitment and Engagement
Strategies for Efficiently Building Public Facing Websites to Promote Participant Recruitment and Engagement
Han Cao
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Study design and statistical analysis exploration of leveraging external controls to accelerate special innovative medical devices registration in China
Study design and statistical analysis exploration of leveraging external controls to accelerate special innovative medical devices registration in China
Cindy MacInnis
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Study Startup Delays and Solutions: Lessons Learned from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study, a Large Pragmatic Basket Trial
Study Startup Delays and Solutions: Lessons Learned from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study, a Large Pragmatic Basket Trial
Weixiao Dai
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Subgroup Analyses in Clinical Trials based on The Desirability of Outcome Ranking (DOOR)
Subgroup Analyses in Clinical Trials based on The Desirability of Outcome Ranking (DOOR)
Heather Hazucha
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Successes and Adaptions of Social Media Campaigns for Recruitment for an Online Clinical Trial for Asthma - Experience from Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Care Outcomes in Adolescents and Young Adults (MATCH)
Successes and Adaptions of Social Media Campaigns for Recruitment for an Online Clinical Trial for Asthma - Experience from Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Care Outcomes in Adolescents and Young Adults (MATCH)
Julia Collins
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
The Accountability Triangle: Strategies for Successful Collaboration between Investigator, Funding Agency, and CRO
The Accountability Triangle: Strategies for Successful Collaboration between Investigator, Funding Agency, and CRO
Mark Forrest
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
The calling dead: Does IVR have a place as a central component in a clinical trial with today’s technology?
The calling dead: Does IVR have a place as a central component in a clinical trial with today’s technology?
Chen Yao
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
The construction of the integrated solution tools for clinical data collection, governance, and management according to the ALCOA + standard Principle
The construction of the integrated solution tools for clinical data collection, governance, and management according to the ALCOA + standard Principle
Azzolina Danila
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
The dichotomizing dilemma in balancing propensity score estimation for a continuous dose-response model in the pediatric trial: a simulation study.
The dichotomizing dilemma in balancing propensity score estimation for a continuous dose-response model in the pediatric trial: a simulation study.
Yijie He
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
The DOOR is open: A Web-based Application for Desirability of Outcome Ranking Analyses
The DOOR is open: A Web-based Application for Desirability of Outcome Ranking Analyses
Bryce Wiley
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
The Impact of the Interactions between Study Drug Shipment Protocols and Randomization Algorithms on Clinical Trial Operations and Costs
The Impact of the Interactions between Study Drug Shipment Protocols and Randomization Algorithms on Clinical Trial Operations and Costs
Annastazia Learoyd
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
The important of Learning stage in establishing the efficacy in multi-stage clinical trial designs
The important of Learning stage in establishing the efficacy in multi-stage clinical trial designs
Matteo Quartagno
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
The Multi-Arm Multi-Stage Response Over Continuous Intervention (MAMS-ROCI) design: a practical design to optimise treatment administration
The Multi-Arm Multi-Stage Response Over Continuous Intervention (MAMS-ROCI) design: a practical design to optimise treatment administration
Matthew Gooden
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
The Need for Continued Education and Training Opportunities in Clinical Research: A Case Study of a 100% Audit
The Need for Continued Education and Training Opportunities in Clinical Research: A Case Study of a 100% Audit
Hannah Moyer
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
The Prevalence and Impact of Bypassing Phase 2 Trial Results Before Phase 3 Trials in Neurology
The Prevalence and Impact of Bypassing Phase 2 Trial Results Before Phase 3 Trials in Neurology
Jonathan Cook
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
The properties of the days alive and at home by day 30 (DAH30) outcome - a simulation study using linear regression
The properties of the days alive and at home by day 30 (DAH30) outcome - a simulation study using linear regression
Cody Chiuzan
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
The Role of Real World Evidence (RWE) in FDA Drug Approval Process
The Role of Real World Evidence (RWE) in FDA Drug Approval Process
Chengwu Yang
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
The Seamless Case-Control, Cohort, and Randomized Controlled Trials Design (SCTD) for High-Quality Evidence in Quantitative Population Health Sciences
The Seamless Case-Control, Cohort, and Randomized Controlled Trials Design (SCTD) for High-Quality Evidence in Quantitative Population Health Sciences
Lu Mao
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Educational Session
The statistical analysis of composite time-to-event outcomes
The statistical analysis of composite time-to-event outcomes
J Athene Lane
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
THREE VIRTUAL METHODS OF CLINICAL OUTCOME ASCERTAINMENT IN A PROSTATE CANCER TREATMENT TRIAL
THREE VIRTUAL METHODS OF CLINICAL OUTCOME ASCERTAINMENT IN A PROSTATE CANCER TREATMENT TRIAL
Thomas Stewart
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Time to Sustained Recovery between Oral Tablet and Inhaler Placebos in the ACTIV-6 Platform Clinical Trial
Time to Sustained Recovery between Oral Tablet and Inhaler Placebos in the ACTIV-6 Platform Clinical Trial
Scott Rushing
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Tracking a Million Samples in the MoTrPAC Study
Tracking a Million Samples in the MoTrPAC Study
Colleen Allen
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Trials and Tribulations of Adapting a Clinical Trials Mindset to Develop an Observational Longitudinal Follow-up Study or Registry
Trials and Tribulations of Adapting a Clinical Trials Mindset to Develop an Observational Longitudinal Follow-up Study or Registry
Amber Boose
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Updating Case Report Forms Using a Cross-Functional Team Approach
Updating Case Report Forms Using a Cross-Functional Team Approach
Giulia Lorenzoni
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Use of Sequential Multiple Assignment Randomized Trials (SMARTs) In Oncology: Systematic Review of Published Studies
Use of Sequential Multiple Assignment Randomized Trials (SMARTs) In Oncology: Systematic Review of Published Studies
Eunji Jo
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Using REDCap for OPTIMISE trial with three participant types
Using REDCap for OPTIMISE trial with three participant types
Jon Salmanton-García
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
VACCELERATE: Volunteer Registry: A European Study Participant Database to Facilitate Clinical Trial Enrolment
VACCELERATE: Volunteer Registry: A European Study Participant Database to Facilitate Clinical Trial Enrolment
Wen Su
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Wasserstein GAN-based Estimation for Conditional Distribution Function with Current Status Data
Wasserstein GAN-based Estimation for Conditional Distribution Function with Current Status Data
Gemma Ainsworth
2023 (Baltimore) Annual Meeting
2023 (Baltimore) Annual Meeting
Contributed Session
Work Smarter, Not Harder: Using Efficient Optimisation to Solve a Multi-parameter Sample Size Problem in the NIFTy Trial
Work Smarter, Not Harder: Using Efficient Optimisation to Solve a Multi-parameter Sample Size Problem in the NIFTy Trial