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 July 27: Pilot Study for a Pragmatic Trial Comparing Chlorthalidone and Hydrochlorothiazide: Results and Lessons LearnedJuly 27 @ 1:00 pm - 2:00 pm
Grand Round August 3: A Digital Pragmatic Direct-to-Participant Clinical Trial for Identifying Undiagnosed Atrial Fibrillation in a Large Health Plan PopulationAugust 3 @ 1:00 pm - 2:00 pm
Grand Rounds August 10: Using a Novel mHealth Platform to Obtain Real-World Data for Post-Market Surveillance: A NEST Demonstration ProjectAugust 10 @ 1:00 pm - 2:00 pm
Grand Rounds August 17: The PCORnet Bariatric Study: Preliminary Results from a Large PCORnet Demonstration ProjectAugust 17 @ 1:00 pm - 2:00 pm
- July 17, 2018: New Podcast: Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing In a new episode of the NIH Collaboratory Grand Rounds podcast, Dr. Michelle Mello discusses a study she and Dr. Steven Goodman recently conducted to determine how clinical trial participants think about ...
- July 16, 2018: JAMA Editorial Highlights mSToPS Trial, Discusses Strengths and Challenges of Pragmatic Clinical Trials An recent editorial in JAMA highlights the mHealth Screening to Prevent Strokes (mSToPS) randomized clinical trial in a discussion of the strengths and challenges of pragmatic clinical trials. The mSToPS ...
- July 3, 2018: New Podcast: Rethinking University Research with State Data In a new episode of the NIH Collaboratory Grand Rounds podcast, Dr. Aaron McKethan discusses the idea of rethinking research with state-level data. Dr. McKethan serves as a faculty member in the ...