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 October 25: Real-World Evidence for Drug Effectiveness Evaluation: Addressing the Credibility GapOctober 25 @ 1:00 pm - 2:00 pm
- November 1 @ 1:00 pm - 2:00 pm
- November 22 @ 1:00 pm - 2:00 pm
- November 29 @ 1:00 pm - 2:00 pm
- October 15, 2019: Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials at Johns Hopkins The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. This position includes pursuing independent research, working ...
- October 11, 2019: Guiding Good Choices for Health (GGC4H) Pragmatic Trial Enrolls First Participant The GGC4H Demonstration Project, now in its implementation phase, has begun enrollment of study participants. Congratulations to Drs. Kuklinski, Sterling, and Catalano and the entire GGC4H study team! GGC4H is a ...
- Podcast October 1, 2019: Preparing for Clinical Trial Data Sharing and Re-use: The New Reality for Researchers (Rebecca Li, PhD, Frank Rockhold, PhD) In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez sits down with Drs. Rebecca Li and Frank Rockhold to discuss clinical trial data sharing and re-use. In the ...