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 August 24: FoodSwitch USA: A Mobile Platform for Packaged Food Surveillance and Behavioral ResearchAugust 24 @ 1:00 pm - 2:00 pm
Grand Rounds September 21: Returning Individual Research Results to Participants: Guidance for a New Research ParadigmSeptember 21 @ 1:00 pm - 2:00 pm
Grand Rounds September 28: Assessing and reducing risk of re-identification when sharing sensitive research datasetsSeptember 28 @ 1:00 pm - 2:00 pm
Grand Rounds October 12: MDEpiNet RAPID and SPEED Projects: Leveraging Real World Evidence to Get Better, Faster, Cheaper Medical Devices for Physicians and PatientsOctober 12 @ 1:00 pm - 2:00 pm
- August 14, 2018: Interview With NIH Collaboratory Leadership Highlights New Demonstration Projects In a recent video interview, NIH Collaboratory leaders Dr. Lesley Curtis, Dr. Adrian Hernandez, and Dr. Catherine Meyers share their enthusiasm for the Collaboratory’s 6 new Demonstration Projects. The projects include ...
- August 13, 2018: JAMA Commentary Highlights the Value of Data Enclaves and Distributed Data Networks In a JAMA Viewpoint published online last week, NIH Collaboratory investigator Dr. Richard Platt and colleague Dr. Tracy Lieu discuss the value of “data enclaves” to facilitate information sharing in support of research, quality ...
- August 10, 2018: STOP CRC Trial Finds Higher Rates of Colorectal Cancer Screening in Community Clinics Using an EHR-Based Outreach Tool The primary results of the Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC) trial, an NIH Collaboratory Demonstration Project, were published online this week in JAMA ...