We are facing an unprecedented time with the challenges of the COVID-19 pandemic. This global emergency has raised many difficult questions, such as how to: identify who is infectious, determine who may need what levels of hospital care, discover modifiable risk factors, determine best predict prognosis, establish best practices for ethical resource allocation, and determine which drugs are viable for specific patient cohorts, and many others.
The CDC COVID-19 Community Survey Question Bank contains potential questions for community surveys and is offered by the CDC to interested researchers. It is not an official CDC form or data collection instrument. You can export the form or individual questions, but you need to be logged into the NIH CDE Repository with a UMLS account to do so. Sign up for a UMLS account here: https://uts.nlm.nih.gov/license.html.
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. See listed clinical studies related to the coronavirus disease (COVID-19)
Cochrane provides high-quality, relevant, and up-to-date synthesized research evidence to inform health decisions. This page highlights content relating to the coronavirus (COVID-19) pandemic and the various related activities that Cochrane is undertaking in response.
The Defense Department is working closely with the Department of Health and Human Services and the State Department to provide support in dealing with the coronavirus outbreak.
We can find effective treatments for COVID-19 much faster by sharing protocols for randomized clinical trials. This platform is a home for RCT protocols that are available for collaboration.
We are tracking the COVID-19 spread in real-time on our interactive dashboard with data available for download. We are also modeling the spread of the virus. Preliminary study results are discussed on our blog.
As part of a larger effort to increase efficiencies and streamline infrastructure for clinical trials, the Stanford Quantitative Sciences Unit (QSU) has established a registry of experts who are interested in serving on (as a member or chair) and/or supporting (as an independent statistician) one or more data and safety monitoring boards (DSMBs) for trials studying interventions related to COVID-19. This registry is publicly available to researchers who are convening a DSMB. It is intended to be a tool to expedite the process and to fulfill the unique DSMB needs for COVID-related trials. The registry may potentially serve future trial needs as well.
In response to the coronavirus pandemic, the ASA has established an online community, COVID-19 Data, Statistics, Research, and Discussion. This is a place for members to share their work, post resources, make new connections, and discuss questions related to COVID-19 research.
The COVID-19 Endpoint Registry developed and maintained by the Stanford Quantitative Sciences Unit contains all US approved primary endpoints to address the challenge in identifying the right endpoint in COVID trials. The purpose of this registry is to provide guidance in designing studies by describing primary endpoints. More specifically, the registry provides data on which endpoints are used to address primary objectives and includes information on study population, sample size, endpoint class or family and how these definitions change over time.
Trials is implementing a new, simplified process for handling COVID-19 trial protocols. Read the Editorial, COVID-19 randomised trial protocols: rapid publication without barriers for more information. We will endeavour to get back to all inquiries within 24 hours.
Conducting trials of novel interventions during infectious disease emergencies, such as the ongoing Covid-19 pandemic, is increasingly recognized as important for determining the efficacy of potential vaccines and therapies. Clinical trials to evaluate investigational interventions are being implemented as part of the broader efforts to control the spread of an infectious disease and to improve patient outcomes. In such circumstances, however, it can be challenging to acquire the necessary evidence about the effects of the interventions to inform future patient care and public health planning, in part because of the unpredictable size, geographic location, and duration of outbreaks.
As the evolving COVID-19 pandemic continues, the clinical trial community and regulatory agencies have taken extraordinary measures to mitigate the negative effect the virus has on the conduct of clinical trials. In response to the pandemic, the FDA and EMA drafted guidance on the actions that sponsors of affected clinical trials should take to help ensure the integrity of their studies, and the interpretation of the study results, while safeguarding the safety of trial participants as a first priority.
European Union clinical trials for COVID-19
The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic.
The European Medicines Agency (EMA), Good Clinical Practice (GCP) Inspectors Working Group, the Clinical Trials Facilitation and Coordination Group (CTFG, a working group of the Heads of Medicines Agency (HMA)), the Clinical Trials Expert Group (CTEG, a working group of the European Commission representing Ethics Committees and National Competent Authorities) and the European Commission (EC) acknowledge the impact of COVID-19 on the health system and broader society, and the impact it may have on clinical trials and trial participants1 . Extraordinary measures may need to be implemented and trials adjusted due to e.g. trial participants being in self-isolation/quarantine, limited access to public places (including hospitals) due to the risk of spreading infections, and health care professionals being committed to critical tasks. Therefore, EMA, EC and HMA strongly support the efforts of the GCP Inspectors’ Working Group for developing a harmonised EU/EEA-level guidance to mitigate the negative effects of the COVID-19 pandemic on the conduct of clinical trials.
The ISRCTN registry is a primary clinical trial registry recognised by WHO and ICMJE that accepts all clinical research studies (whether proposed, ongoing or completed), providing content validation and curation and the unique identification number necessary for publication. All study records in the database are freely accessible and searchable.
Randomized clinical trials provide the highest-quality evidence for identifying therapies to help people attain longer and healthier lives...
The Department of Homeland Security (DHS) Science and Technology Directorate (S&T) developed the following “master question list” that quickly summarizes what is known, what additional information is needed, and who may be working to address such fundamental questions as, “What is the infectious dose?” and “How long does the virus persist in the environment?” The Master Question List (MQL) is intended to quickly to present the current state of available information to government decision makers in the operational response to COVID-19 and allow structured and scientifically guided discussions across the federal government without burdening them with the need to review scientific reports, and to prevent duplication of efforts by highlighting and coordinating research.
The COVID-19 outbreak has implications for ongoing research with millions of people currently participating in clinical trials...
Latest resources and news releases from the NIH for Coronavirus (COVID-19)
LitCovid is a curated literature hub for tracking up-to-date scientific information about the 2019 novel Coronavirus. It is the most comprehensive resource on the subject, providing a central access to 10691 (and growing) relevant articles in PubMed. The articles are updated daily and are further categorized by different research topics and geographic locations for improved access. You can learn more at Chen et al. Nature (2020) or our FAQ, and download our data here.
This guidance represents the current thinking of the Office for Human Research Protections (OHRP) on this topic.
Researchers across the University of Oxford are at the forefront of global efforts to understand the coronavirus (COVID-19) and protect our communities.
The FDA is working to address the coronavirus disease (COVID-19) outbreak and keep you and your family informed on the latest developments. In case you missed it, here is the latest information for consumers on this important topic:
A clinical trial led by the University of Minnesota on a post-exposure treatment for the coronavirus (COVID-19) is expanding participant enrollment opportunities.
Dr. Mike Lauer, NIH Deputy Director for Extramural Research, provides updates for the research community on flexibilities NIH is providing the community due to the COVID-19 public health emergency.
This week, stakeholders from across the clinical trials ecosystem submitted experiences and insights related to the FDA’s new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. The Clinical Trials Transformation Initiative (CTTI) collated the feedback – including insights safety considerations, remote study visits, remote consent, consulting with IRBs, and more – and will share the findings and best practices via a webinar on Tuesday, March 31 at 11:15 a.m. ET.
WHO is gathering the latest international multilingual scientific findings and knowledge on COVID-19. The global literature cited in the WHO COVID-19 database is updated daily (Monday through Friday) from searches of bibliographic databases, hand searching, and the addition of other expert-referred scientific articles. This database represents a comprehensive multilingual source of current literature on the topic. While it may not be exhaustive, new research is added regularly.
What Physicians Need to Know During the COVID-19 pandemic, many physicians are working from home, using their personal computers and mobile devices to help care for patients. Fortunately, technology can allow physicians and care teams to do much of what they could do at the medical office, remotely. Telemedicine is a powerful tool that spans a continuum of technologies and offers new ways to deliver care. Many electronic health record (EHR) systems allow you to connect over the Internet just as if you were in the clinic. While you are doing your part to help during the COVID-19 pandemic, the American Medical Association (AMA) and American Hospital Association (AHA) want to ensure you have resources to help keep your work environment safe from cyber-threats that could disrupt your practice, the hospital, or negatively impact your patients’ safety and well-being.
COVID-19 CORONAVIRUS PANDEMIC Cases, Deaths, Recovered and Statistics