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 June 21: A Polypill Strategy for Cardiovascular Prevention in Underserved Populations – Can We Bridge the Gap?June 21 @ 1:00 pm - 2:00 pm
- June 28 @ 1:00 pm - 2:00 pm
- July 5 @ 1:00 pm - 2:00 pm
Grand Rounds July 12: medRxiv: A Paradigm Shift in Disseminating Clinical and Public Health ResearchJuly 12 @ 1:00 pm - 2:00 pm
- June 20, 2019: EMBED Investigators Discuss Progress and Transition to Implementation Phase At the May 2019 meeting of the NIH Collaboratory Steering Committee, we talked with Drs. Ted Melnick and Gail D’Onofrio of EMBED, an NIH Collaboratory Demonstration Project, to hear about ...
- June 13, 2019: Experience With Pragmatic Clinical Trials Gains Momentum At the NIH Collaboratory Steering Committee Meeting in May 2019, participants shared their perspectives on the evolving landscape of embedded pragmatic clinical trials (ePCTs). Three initiatives were presented: the Patient-Centered ...
- June 11, 2019: NIH Collaboratory Hosts Daylong ePCT Seminar at AcademyHealth Annual Research Meeting Nearly 50 researchers attended a preconference seminar at the 2019 AcademyHealth Annual Research Meeting in Washington, DC, to learn the essentials of embedded pragmatic clinical trials (ePCTs). The full-day seminar, ...