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
Grand Rounds March 1: Approaches to Patient Follow-Up for Clinical Trials: What’s the Right Choice for You?March 1 @ 1:00 pm - 2:00 pm
- March 22 @ 1:00 pm - 2:00 pm
- February 22, 2019: Proposed Rule to Implement Provisions of the 21st Century Cures Act The Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid (CMS) have announced a proposed rule intended to advance interoperability and support ...
- February 21, 2019: Living Textbook Offers New Content on Design and Analysis of Pragmatic Clinical Trials Members of the NIH Collaboratory’s Biostatistics and Study Design Core contributed 3 new sections to the Living Textbook exploring issues in the design and analysis of pragmatic clinical trials. The new ...
- Podcast February 19, 2019: Paramedic Airway Management in Out-of-Hospital Cardiac Arrest – The Pragmatic Airway Resuscitation Trial (PART) In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez sits down with Dr. Henry Wang to discuss The Pragmatic Airway Resuscitation Trial (PART); a trial that took 10 years ...