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 January 17: Assessment of the Human Systemic Absorption of Sunscreen Active Ingredients: FDA-Sponsored Randomized Clinical TrialJanuary 17 @ 1:00 pm - 2:00 pm
IMPACT Collaboratory Grand Rounds January 23: Using a Pilot to Test and Refine Your Measurement StrategyJanuary 23 @ 12:00 pm - 1:00 pm
- January 24 @ 1:00 pm - 2:00 pm
- January 31 @ 1:00 pm - 2:00 pm
- January 16, 2020: NIH Collaboratory Investigators Describe Key Elements of Successful Distributed Research Networks Members of the NIH Collaboratory Distributed Research Network (DRN) have helped build DRNs for the Sentinel System, the NIH Collaboratory, and the National Patient-Centered Clinical Research Network (PCORnet). In a ...
- January 15, 2020: NIH Collaboratory Announces Data and Resource Sharing Page The NIH Collaboratory Coordinating Center has published a new Data and Resource Sharing Page on the Living Textbook, which is designed to share the data and resources generated by the ...
- January 13, 2020: National Library of Medicine Launches a Modernization of ClinicalTrials.gov As the National Library of Medicine (NLM) celebrates 20 years of ClinicalTrials.gov, a new multi-year initiative is underway to modernize and enhance the user experience of this public resource. To ...