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
- January 18 @ 1:00 pm - 2:00 pm
Grand Rounds January 25: A Learning Health System Story: Perinatal Outcomes Associated with a Major Change in Gestational Diabetes ScreeningJanuary 25 @ 1:00 pm - 2:00 pm
Grand Rounds February 1: Promoting Effective Advance Care Planning Communication in the Elderly: The ACP-PEACE TrialFebruary 1 @ 1:00 pm - 2:00 pm
Grand Rounds February 8: Paramedic Airway Management in Out-of-Hospital Cardiac Arrest – The Pragmatic Airway Resuscitation Trial (PART)February 8 @ 1:00 pm - 2:00 pm
- January 11, 2019: FDA Releases Framework for Evaluating the Use of Real-World Evidence To help fulfill the requirements of the 21st Century Cures Act by accelerating medical product development and fostering innovation and advances in medicine, FDA recently created a framework for evaluating ...
- December 17, 2018: NIH Collaboratory Advances Knowledge in Peer-Reviewed Literature in 2018 The NIH Collaboratory program contributed knowledge from pragmatic clinical research with 12 peer-reviewed publications in 2018, including several reports of findings from Demonstration Projects and more: NIH Collaboratory Coordinating Center Identifying and ...
- December 14, 2018: New Alzheimer Trial to Be Planned Using the NIH Collaboratory Distributed Research Network A new pragmatic trial planning grant supported by the National Institute on Aging will use the NIH Collaboratory’s Distributed Research Network (DRN) to characterize eligible patients and develop an intervention ...