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
- March 30 @ 1:00 pm - 2:00 pm
Grand Rounds April 13: OHDSI: Drawing Reproducible Conclusions from Observational Clinical Data (George Hripcsak, MD, MS)April 13 @ 1:00 pm - 2:00 pm
- NIH Course on Biostatistics of Pragmatic and Group-Randomized Trials - Free 7-part online course
- March 22, 2018: New Podcast: Dr. Sean Tunis and Ellen Tambor on Clinicians’ Views on Participating in CER/PCOR The NIH Collaboratory is pleased to announce that the new episode of the Grand Rounds podcast is now available, featuring Dr. Sean Tunis and Ellen Tambor of the Center for Medical Technology Policy (CMTP). In this episode, the speakers discuss with moderator Dr. Kevin Weinfurt their findings on clinician attitudes towards research participation, and how and ...
- March 21, 2018: Dr. Rob Califf to Speak on Data Science at March 23 Grand Rounds Robert Califf, MD, former FDA Commissioner and current Vice Chancellor for Health Data Science at Duke University School of Medicine, will present at NIH Collaboratory Grand Rounds on Friday, March 23 at 1 pm ET. The webinar will be broadcast live and is open to the public. Following the presentation, Dr. Califf will answer questions from ...
- March 15, 2018: New Resource for Understanding Ethical and Regulatory Architecture of Patient-Centered Outcomes Research Data Using patient-centered outcomes research (PCOR) data requires balancing the need for sufficient private health information to support meaningful research with the need to protect patient privacy and autonomy. In support of this dual goal, The Office of the National Coordinator for Health Information Technology (ONC) has just released a document that provides a collection of ...
- New Grand Rounds Podcasts
- 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