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
- March 29 @ 1:00 pm - 2:00 pm
- April 5 @ 1:00 pm - 2:00 pm
Grand Rounds April 19: The Trauma Survivors Outcomes & Support (TSOS) Pragmatic Trial : Revisiting Effectiveness & Implementation AimsApril 19 @ 1:00 pm - 2:00 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
- March 13, 2019: PROVEN Publishes Study of Nursing Home Characteristics Associated With Implementation of an Advance Care Planning Video Intervention The Collaboratory Demonstration Project Pragmatic Trial of Video Education in Nursing Homes (PROVEN) is testing the effectiveness of a novel advance care planning (ACP) video education program in 360 nursing ...
- March 6, 2018: Results of the Active Bathing to Eliminate (ABATE) Infection Trial Published in The Lancet The Active Bathing to Eliminate (ABATE) Infection trial compared routine bathing to decolonization with universal chlorhexidine and targeted nasal mupirocin in non-critical-care units. Similar interventions have been found to reduce ...
- March 5, 2019: New Living Textbook Section on Using Death as an Endpoint Using death as an endpoint in pragmatic clinical trials is challenging because there are no standardized processes for ascertaining patient deaths in the United States. If a patient dies outside ...