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 19: The Healthcare Pivot: Technology and Transformation of Healthcare (Kevin A. Schulman, MD)January 19 @ 1:00 pm - 2:00 pm
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
- NIH Course on Biostatistics of Pragmatic and Group-Randomized Trials - Free 7-part online course
- January 10, 2018: NCI Announces Training Institute in Dissemination and Implementation Research in Cancer The National Cancer Institute’s Division of Cancer Control & Population Sciences is accepting applications for a Training Institute in Dissemination and Implementation Research in Cancer (TIDIRC). Designed for investigators at all levels who conduct dissemination and implementation research in cancer control, the training institute will consist of a 4-month online course and a 2-day in-person ...
- January 10, 2018: New Podcast: Drs. Richard Platt and Christopher Granger discuss IMPACT-AFib and the Role of Sentinel The NIH Collaboratory is pleased to announce that the new episode of the Grand Rounds podcast is now available, featuring Dr. Richard Platt of Harvard Pilgrim Health Care Institute and Dr. Christopher Granger of Duke University. In this episode, Drs. Platt and Granger speak with moderator Dr. Adrian Hernandez about the IMPACT-AFib atrial fibrillation trial and ...
- December 18, 2017: New Podcast: Drs. Greg Simon and Susan Ellenberg Discuss Data and Safety Monitoring in Pragmatic Trials The NIH Collaboratory is pleased to announce that the new episode of the Grand Rounds podcast is now available, featuring Dr. Greg Simon, principal investigator on the Suicide Prevention Outreach Trial (SPOT), and Dr. Susan Ellenberg of the Regulatory/Ethics Core. In this episode, Drs. Simon and Ellenberg discuss the need for a data and safety monitoring plan in any clinical ...
- 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