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 November 15: PCORnet: Health Plan Research Network Data Linkage and Patient Engagement with Patient-Powered Research NetworksNovember 15 @ 1:00 pm - 2:00 pm
IMPACT Collaboratory: Are You Ready for a Pragmatic Trial? The RAPT Model and Implementation ConsiderationsNovember 21 @ 12:00 pm - 1:00 pm
- November 22 @ 1:00 pm - 2:00 pm
- November 29 @ 1:00 pm - 2:00 pm
- November 1, 2019: Collaboratory PIs Give Advice to New Pragmatic Trials The NIH Health Care Systems Research Collaboratory program is welcoming new embedded pragmatic clinical trials (ePCTs) on pain management and reducing opioid prescribing as part of the NIH’s Helping to ...
- October 30, 2019: Baseline Covariate Imbalance Influences Treatment Effect Bias in Cluster Randomized Trials In a study supported by the NIH Collaboratory, researchers found that imbalance in individual-level baseline covariates influences bias in the observed treatment effect in cluster randomized trials. Using race as ...
- October 28, 2019: Latest Ethics and Regulatory Updates from Demonstration Projects Available Six Collaboratory Demonstration Projects—ACP PEACE, EMBED, GGC4H, HiLo, Nudge, and PRIM-ER—have recently transitioned from the planning to implementation phase of their embedded pragmatic clinical trial (ePCT). During the transition, study ...