Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials
Welcome to the Living Textbook of pragmatic clinical trials, a collection of knowledge from the NIH Health Care Systems Research Collaboratory. Pragmatic clinical trials are performed in real-world clinical settings with highly generalizable populations to generate actionable clinical evidence at a fraction of the typical cost and time needed to conduct a traditional clinical trial. They present an opportunity to efficiently address critical knowledge gaps and generate high-quality evidence to inform medical decision-making. However, these trials pose different challenges than are typically encountered with traditional clinical trials. The Living Textbook reflects a collection of expert consensus regarding special considerations, standard approaches, and best practices in the design, conduct, and reporting of pragmatic clinical trials. Given the rapid pace of change in this field, this electronic textbook will continue to be added to and updated.
By sharing lessons from our experience with pragmatic research, we aim to facilitate large-scale collaborative research studies with healthcare systems. The Living Textbook relies on the following knowledge sources:
DEMONSTRATION PROJECTS: Pragmatic clinical
trials that address questions of major public health importance and provide proof of concept for innovative pragmatic research designs.
CORES: Working groups that support the conduct of Demonstration Projects and generate guidance addressing implementation challenges.
DISTRIBUTED RESEARCH NETWORK: Network enabling investigators to collaborate in the use of electronic health data while safeguarding protected health information.
Upcoming Learning Opportunities
Grand Rounds January 26: The Lumbar Imaging with Reporting of Epidemiology (LIRE) Trial: Subsequent Cross-Sectional Imaging Through 90 Days- Preliminary Results (Jeffrey Jarvik, MD, MPH; Patrick Heagerty, PhD)January 26 @ 1:00 pm - 2:00 pm
Grand Rounds February 2: Early Progress on the All of Us Research Program (Joshua C. Denny, MD, MS, FACMI)February 2 @ 1:00 pm - 2:00 pm
- NIH Course on Biostatistics of Pragmatic and Group-Randomized Trials - Free 7-part online course
- January 19, 2018: New Research Methods Resources Website on Group- or Cluster-Randomized Studies The National Institutes of Health (NIH) Office of Extramural Research has released new clinical trial requirements for grant applications and contract proposals due on or after January 25, 2018. In anticipation of these new requirements, the NIH modified the Application Guide and the Review Criteria to address methodological problems common to many clinical trials. As ...
- January 18, 2018: Implementation of Revised Common Rule Delayed On January 17, 2018, the Department of Health and Human Services and 15 other federal departments and agencies announced a delay to both the effective and compliance dates for the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule). Most provisions in the revised Common Rule were ...
- January 17, 2018: The “All of Us” Research Program Asks for Research Ideas The groundbreaking “All of Us” research program, which aims to enroll and track more than a million people, is asking prospective researchers, community organizations, and citizen scientists for suggestions regarding potential research questions. Ideas can be submitted through a special research page and are due by February 19, 2018. At a Research Priorities Workshop in ...
- New Grand Rounds Podcasts
- Moderators’ Edition: Discussion of the Future of the NIH Collaboratory (Moderators' Edition)
- Bringing Machine Learning to the Point of Care to Improve Suicide Prevention (Greg Simon, MD, MPH)
- Health Is More Than Healthcare (Karen DeSalvo, MD, MPH, MSc)
- Preprints: What, Why Not, and How (Harlan Krumholz, MD)
- NIH Collaboratory policies and guidance documents
- NIH Collaboratory milestone timeline
- Demonstration Projects: Regulatory and Ethics Discussions
- Stakeholder Interviews with Collaboratory Cores and Demonstration Projects