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 10: Hydroxychloroquine for the Early Treatment of COVID-19 in Hospitalized Adults: A Multicenter Randomized Clinical TrialApril 10 @ 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
Living Textbook Grand Rounds Series June 19: Part 5-Demystifying Biostatistical Concepts for Embedded Pragmatic Clinical TrialsJune 19 @ 1:00 pm - 2:00 pm
- March 26, 2020: Latest NIH Collaboratory Podcast Now Available The latest episode of the NIH Collaboratory Grand Rounds Podcast is now available on the Living Textbook. “Creating a Learning Health System Through Randomization” features a discussion between the NIH ...
- March 24, 2020: Impacts of COVID-19 on the Conduct of Clinical Trials In a recent PCT Grand Rounds, Drs. Naggie, Hernandez, and Perakslis of Duke University discussed the impacts of the COVID-19 outbreak on the conduct of clinical trials. The panel described ...
- March 17, 2020: Cheat Sheet on the Intraclass Correlation Coefficient The NIH Collaboratory Biostatistics and Study Design Core has created an Intraclass Correlation Coefficient (ICC) Cheat Sheet to provide an introductory description of the ICC, which is important for the ...