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
- May 31 @ 1:00 pm - 2:00 pm
Grand Rounds June 14: Good Clinical Practice Guidance and Pragmatic Trials: Balancing the Best of Both Worlds in the Learning Health SystemJune 14 @ 1:00 pm - 2:00 pm
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
- July 5 @ 1:00 pm - 2:00 pm
- May 16, 2019: NIH Collaboratory Investigators Author Recommendations for Responding to Guideline or Policy Changes That Affect Ongoing Pragmatic Trials A new perspective article by NIH Collaboratory investigators describes the unique, unexpected challenges researchers face when clinical practice guidelines and policies change during the conduct of a pragmatic clinical trial ...
- May 14, 2019: NIH Announces 3 New Funding Opportunities in Dissemination and Implementation of Evidence-Based Interventions The NIH published 3 new funding opportunity announcements to support innovative approaches to the implementation of evidence-based interventions and the de-implementation of ineffective interventions. The announcement also encourages studies that ...
- May 13, 2019: JGIM Issues Call for Papers on Implementation Science and Quality Improvement The Journal of General Internal Medicine (JGIM) has announced a call for papers that report findings from research at the intersection of implementation science (IS) and quality improvement (QI). Submissions are ...