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
- December 13 @ 1:00 pm - 2:00 pm
- December 20 @ 1:00 pm - 2:00 pm
- December 27 @ 1:00 pm - 2:00 pm
- January 3, 2020 @ 1:00 pm - 2:00 pm
- December 12, 2019: Two New Studies Highlight Feasibility of Using the Distributed Research Network to Support Pragmatic Trials Two new studies from the NIH Collaboratory’s Distributed Research Network (DRN) demonstrated the feasibility of using administrative data and claims to define populations, identify outcomes, and generate hypotheses in support of pragmatic ...
- November 26, 2019: PRISM Kickoff Meeting Welcomes New Demonstration Projects to NIH Collaboratory The NIH Collaboratory welcomed 4 new Demonstration Project teams last week during a kickoff meeting in Bethesda, Maryland. These pragmatic clinical trials embedded in healthcare systems are funded through the ...
- November 22, 2019: NIH Releases Draft Policy for Data Management and Sharing The NIH recently released a Draft NIH Policy for Data Management and Sharing and supplemental draft guidance for public comment. In the draft, the NIH reiterates its commitment to making available ...