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 June 1: How Would You Build an Academic Medical System to Bridge Research and Care if You Could Start from Scratch? (S. Claiborne “Clay” Johnston, MD, PhD, MPH)June 1 @ 1:00 pm - 2:00 pm
Grand Rounds June 8: Implementation in the PROVEN Trial: Challenges of Conducting PCTs in Nursing Home Health Care Systems (Susan Mitchell MD, MPH; Angelo Volandes, MD, MPH)June 8 @ 1:00 pm - 2:00 pm
- NIH Course on Biostatistics of Pragmatic and Group-Randomized Trials - Free 7-part online course
- May 5, 2018: New Article Explores Opportunities for Funding the Training of Future Health Services Researchers In a new article, Dr. Vincent Mor, an NIH Collaboratory investigator, and Dr. Paul Wallace describe the history, current status, and opportunities for funding training in health services research (HSR). While the number of organizations seeking to solve problems with health services research has been expanding, direct government support for HSR is declining. The authors ...
- May 1, 2018: Proposal for 6-month Delay for Implementation of Revised Common Rule On April 20, 2018, the Department of Health and Human Services and 15 other federal departments and agencies proposed a rule to delay both the effective and compliance dates for the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule). The Interim Final Rule initially announced a ...
- April 27, 2018: Collaboratory Investigators Pen Editorial Calling for Pragmatic Trials of Nonpharmacologic Dementia Interventions NIH Collaboratory investigators Dr. Susan Mitchell and Dr. Vincent Mor coauthored an editorial for an upcoming issue of JAMDA highlighting the need for pragmatic trials of nonpharmacologic interventions in Alzheimer disease and related dementias. The editorial summarizes conclusions from a recent workshop at the National Institute on Aging (NIA), where experts discussed the state of ...
- 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