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 February 23: Direct Mail Programs Work… But Will Health Centers Implement Them? Findings from STOP CRC (Gloria D. Coronado, PhD; Beverly B. Green, MD, MPH)February 23 @ 1:00 pm - 2:00 pm
Grand Rounds March 2: Distributed Research Network Querying: A Status Report (Jeff Brown, PhD; Lesley H. Curtis, PhD; Richard Platt, MD, MSc)March 2 @ 1:00 pm - 2:00 pm
- NIH Course on Biostatistics of Pragmatic and Group-Randomized Trials - Free 7-part online course
- February 20, 2018: National Academies Release Workshop Summary on Real-World Evidence in Medical Product Development The National Academies of Sciences, Engineering, and Medicine released a summary of the first workshop in a 3-part series on the development and use of real-world evidence in medical product development. The report, Examining the Impact of Real-World Evidence on Medical Product Development: I. Incentives, focuses on the role of incentives in supporting the collection ...
- February 19, 2018: New Podcast: Dr. Andrew Faucett on Considerations for the Return of Genomic Results The NIH Collaboratory is pleased to announce that the new episode of the Grand Rounds podcast is now available, featuring Dr. Andrew Faucett of Geisinger. In this episode, Dr. Faucett speaks with moderator Dr. Lesley Curtis about the scalability of returning genomic research to clinicians and patients, considering issues like technical validity and sample identity in genetic variants. He also ...
- February 15, 2018: Timely Tips from Demonstration Project Principal Investigators The NIH Collaboratory will soon welcome a new group of Demonstration Projects and guide them through the piloting and implementation phases of their embedded pragmatic clinical trials (ePCTs). We asked three seasoned principal investigators—Drs. Laura Dember, MD (TiME), Lynn DeBar, PhD (PPACT), and Jerry Jarvik, MD, MPH (LIRE)—to share tips and advice for investigators who ...
- New Grand Rounds Podcasts
- IMPACT-AFib: An 80,000 Person Randomized Trial Using the Sentinel Initiative Platform (Richard Platt, MD, MS; Christopher Granger, MD, FACC, FAHA)
- Data and Safety Monitoring in Pragmatic Clinical Trials (Greg Simon, MD, MPH, and Susan Ellenberg, PhD)
- Moderators’ Edition: Discussion of the Future of the NIH Collaboratory (Moderators' Edition)
- NIH Collaboratory policies and guidance documents
- NIH Collaboratory milestone timeline
- Demonstration Projects: Regulatory and Ethics Discussions
- Stakeholder Interviews with Collaboratory Cores and Demonstration Projects