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.
Pragmatic clinical trials that address questions of major public health importance and provide proof of concept for innovative pragmatic research designs.
Working groups that support the conduct of Demonstration Projects and generate guidance addressing implementation challenges.
Network enabling investigators to collaborate in the use of electronic health data while safeguarding protected health information.
Upcoming Learning Opportunities
Living Textbook Grand Rounds Series February 28: Part 2-Preparing for the Unknown: Conducting Pragmatic Research in Real-World ContextsFebruary 28 @ 1:00 pm - 2:00 pm
- March 6 @ 1:00 pm - 2:00 pm
Grand Rounds March 13: Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus–Lessons Learned and Future DirectionsMarch 13 @ 1:00 pm - 2:00 pm
- March 19 @ 8:00 am - March 20 @ 5:00 pm
- February 24, 2020: Study Snapshots for Six UH3 Demonstration Projects Are Available Want to know more about the goals and challenges of the NIH Collaboratory’s Demonstration Projects? New downloadable handouts summarize the study aims, implementation lessons, and recent publications and presentations from ...
- February 21, 2020: New Video Interviews Highlight Goals of the NIH HEAL Initiative and PRISM Demonstration Projects Recently, the Collaboratory Coordinating Center conducted video interviews describing the critical work being done in the NIH HEAL Initiative program to address the national opioid crisis. As part of this ...
- February 11, 2020: ADAPTABLE Roundtable Produces Consensus Statement on Analysis and Integration of Patient-Reported Data in Clinical Trials A roundtable discussion organized by the NIH Collaboratory in 2017 has produced consensus findings on the analysis and integration of patient-reported health (PRH) data in clinical trials. The report is ...