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
- July 19 @ 1:00 pm - 2:00 pm
- July 26 @ 1:00 pm - 2:00 pm
- August 2 @ 1:00 pm - 2:00 pm
- August 16 @ 1:00 pm - 2:00 pm
- July 16, 2019: ACP PEACE Trial Moves From Planning to Implementation Phase: An Interview With Dr. Angelo Volandes The National Institute on Aging (NIA) recently approved the Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP PEACE) trial, an NIH Collaboratory Demonstration Project, to move ...
- July 15, 2019: PRIM-ER Gains Approval to Proceed to Implementation Phase: An Interview With Dr. Corita Grudzen Primary Palliative Care for Emergency Medicine (PRIM-ER), an NIH Collaboratory Demonstration Project, received approval this month to enter its implementation phase. PRIM-ER is a pragmatic, cluster randomized trial of a ...
- July 3, 2019: New Article Describes the Public’s Beliefs Regarding Responsibility to Participate in Research Findings from a new article suggest that the majority of patients do not feel a personal responsibility to participate in clinical research. In the article, Kevin Weinfurt, Li Lin, and ...