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.
By sharing lessons from our experience with pragmatic research, we aim to facilitate large-scale collaborative research studies with healthcare systems. The Living Textbook relies on the following knowledge sources:
DEMONSTRATION PROJECTS: Pragmatic clinical
trials that address questions of major public health importance and provide proof of concept for innovative pragmatic research designs.
CORES: Working groups that support the conduct of Demonstration Projects and generate guidance addressing implementation challenges.
DISTRIBUTED RESEARCH NETWORK: Network enabling investigators to collaborate in the use of electronic health data while safeguarding protected health information.
Upcoming Learning Opportunities
Grand Rounds September 22: Improving Evidence Generation for Medical Devices: The New National Evaluation System for Health Technology (NEST) (Rachael Fleurence, PhD)September 22 @ 1:00 pm - 2:00 pm
- September 29 @ 1:00 pm - 2:00 pm
- NIH Course on Biostatistics of Pragmatic and Group-Randomized Trials - Free 7-part online course
- September 19, 2017: The NIH Health Care Systems Research Collaboratory Turns Five! Five years ago this September marks the birth of the NIH Health Care Systems Collaboratory, an NIH Common Fund project designed to build national infrastructure for conducting pragmatic clinical trials (PCTs). At the heart of the NIH Collaboratory is an ongoing series of Demonstration Projects that embed innovative pragmatic clinical research within the “real-world” conditions ...
- August 25, 2017: NIH Collaboratory Launches New Website With Expert Insight on Pragmatic Trials Today, the NIH Collaboratory launched its new website, Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. The updated website serves as the new home for comprehensive information about the NIH Collaboratory program, as well as a rich source of knowledge about special considerations for pragmatic clinical trials at each step of the research ...
- July 28, 2017: FDA says will not object to waiver of informed consent for minimal risk studies in new guidance In a new guidance, the US Food and Drug Administration (FDA) explains that it does not intend to object to the conduct of a minimal risk clinical study if the institutional review board has waived or altered the requirement for informed consent.