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 April 3: Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): Participant-Centered, Rapidly-Deployed, Digitally-Enabled ResearchApril 3 @ 1:00 pm - 2:00 pm
Grand Rounds April 10: Hydroxychloroquine for the Early Treatment of COVID-19 in Hospitalized Adults: A Multicenter Randomized Clinical TrialApril 10 @ 1:00 pm - 2:00 pm
Grand Rounds April 17: Using Real-World Data to Plan Eligibility Criteria and Enhance Recruitment: Actionable Recommendations and Resources from the Clinical Trials Transformation InitiativeApril 17 @ 1:00 pm - 2:00 pm
Living Textbook Grand Rounds Series May 1: Part 4-Choosing What to Measure and Making it Happen: Your Keys to Pragmatic Trial SuccessMay 1 @ 1:00 pm - 2:00 pm
- April 1, 2020: NIH Collaboratory Holds COVID-19 Grand Rounds Series, Promotes Resources for Research Community Using its popular Grand Rounds platform, the NIH Collaboratory Coordinating Center has launched a new effort to share late-breaking research and promote resources in support of clinical researchers affected by ...
- April 1, 2020: Pre-conference Workshop on Essentials of ePCTs Offered at AcademyHealth 2020 Annual Research Meeting The NIH Collaboratory is partnering with AcademyHealth to offer a full-day pre-conference workshop at the 2020 Annual Research Meeting in Boston. The workshop, Essentials of Embedded Pragmatic Clinical Trials (ePCTs), ...
- March 31, 2020: Engagement in PCTs: Considerations from the Collaboratory’s Ethics and Regulatory Core A new document from the Ethics and Regulatory Core is available that provides considerations around determining which individuals or groups are engaged in research in pragmatic clinical trials (PCTs). Developed ...