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.
Pragmatic clinical trials that address questions of major public health importance and provide proof of concept for innovative pragmatic research designs.
Working groups that support the conduct of Demonstration Projects and generate guidance addressing implementation challenges.
Network enabling investigators to collaborate in the use of electronic health data while safeguarding protected health information.
Upcoming Learning Opportunities
Grand Rounds December 14: Guiding Good Choices for Health (GGC4H): Testing Feasibility and Effectiveness of Universal Parent-Focused Prevention in Three Healthcare SystemsDecember 14 @ 1:00 pm - 2:00 pm
- December 21 @ 1:00 pm - 2:00 pm
- December 28 @ 1:00 pm - 2:00 pm
Grand Rounds January 11: Nudge: Text Messaging at Scale in Diverse Health Systems to Support Adherence to Cardiac MedicationJanuary 11, 2019 @ 1:00 pm - 2:00 pm
- December 11, 2018: Two New NIH Funding Opportunity Announcements for Pragmatic Trials Address the Opioid Crisis The NIH has announced two new funding opportunity announcements (FOAs) for 7 or more embedded pragmatic clinical trials that address pain management and the opioid crisis. These projects will become ...
- Podcast December 5, 2018: Validating a Computable Phenotype: Should Results Change a Trial’s Pre-Specified Primary Outcome? In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Lesley Curtis speaks with Dr. Gregory Simon and Dr. Susan Shortreed of the Kaiser Permanente Washington Health Research Institute. In their conversation, ...
- December 3, 2018: FDA Calls for Comments on Proposed Rule to Allow Exceptions to the Requirement for Informed Consent in Minimal-Risk Research The Food and Drug Administration (FDA) is proposing a rule to allow for a waiver or alteration of informed consent for clinical investigations posing no more than minimal risk to ...