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 26: The VERITAS Trial: Virtual Exercise Rehabilitation at the Intersection of Evidence, Implementation, and PolicyApril 26 @ 1:00 pm - 2:00 pm
- May 2 @ 8:00 am - 4:30 pm
Grand Rounds May 3: Effects of Financial Bonus Sizes, Loss Aversion, and Increased Social Pressure on Physician Pay-for-Performance: A Randomized Trial and Cohort StudyMay 3 @ 1:00 pm - 2:00 pm
- May 10 @ 1:00 pm - 2:00 pm
- April 22, 2019: TiME Trial Confirms Feasibility of Embedding Large Pragmatic Trials in Clinical Care The primary results of the Time to Reduce Mortality in End-Stage Renal Disease (TiME) trial, an NIH Collaboratory Demonstration Project, were published online this month in the Journal of the American ...
- April 18, 2019: New Commentary Highlights Value of Pragmatic Trials for Learning Health Systems In an eGEMs commentary published this month, Leah Tuzzio and Dr. Eric Larson of the NIH Collaboratory’s Health Care Systems Interactions Core discuss the value and impact of embedded pragmatic ...
- April 15, 2019: Registration Now Open for Workshop on the Design & Analysis of Embedded Pragmatic Clinical Trials (ePCT) The NIH Health Care Systems Research Collaboratory is hosting a one-day workshop on the Design & Analysis of Embedded Pragmatic Clinical Trials (ePCTs) on May 2, 2019, in the Lister ...