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
NIH Mind the Gap Webinar: Design and Analysis of Individually Randomized Group-Treatment Trials in Public HealthApril 24 @ 11:00 am - 12:00 pm
Grand Rounds April 27: Expanding Use of Real-World Evidence, a National Academies Workshop Series (Greg Simon, MD, MPH)April 27 @ 1:00 pm - 2:00 pm
- NIH Course on Biostatistics of Pragmatic and Group-Randomized Trials - Free 7-part online course
- April 17, 2018: New Podcast: Dr. George Hripcsak on OHDSI and Drawing Reproducible Conclusions From Observational Clinical Data A new episode of the Grand Rounds podcast is now available, featuring Dr. George Hripcsak, Chair of the Bioinformatics Department at Columbia University. In this episode, Dr. Hripcsak discusses the Observational Health Data Sciences and Informatics (OHDSI) Program with moderator Dr. Adrian Hernandez, and describes the program’s vision to create accessible and reliable clinical evidence by ...
- April 16, 2018 Registration Now Open for Workshop on Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions Registration is now open for a one-day workshop sponsored by the NIH Common Fund and organized by NIH Collaboratory thought leaders. The workshop, to be held on May 16, will focus on expanding the understanding of a specific type of pragmatic trial, the A vs. B trial, which compares two or more distinct therapeutic medical ...
- April 13, 2018: PCORI Launches Tool for Exploring Literature on Engagement in Health Research Seeking to advance the study and practice of engagement in health research, the Patient-Centered Outcomes Research Institute (PCORI) recently launched the Engagement in Health Research Literature Explorer. Locating relevant research articles about engagement can be challenging because of a lack of standard terminology. The new tool searches a curated database of peer-reviewed literature on engagement. ...
- New Grand Rounds Podcasts
- Podcast April 9, 2018: Data Science in the Era of Data Ubiquity (Robert Califf, MD)
- Considerations for the Return of Genomic Results (Andrew Faucett, MS, LGC)
- 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