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
- November 24 @ 1:00 pm - 2:00 pm
Grand Rounds December 1: CIIC – Providing a Shared Repository of Detailed Clinical Models for all of Health and Healthcare (Stanley M. Huff, MD; W. Ed Hammond, PhD)December 1 @ 1:00 pm - 2:00 pm
- NIH Course on Biostatistics of Pragmatic and Group-Randomized Trials - Free 7-part online course
- November 20, 2017: NIH Collaboratory Core Working Group Interviews: Reflections from the Regulatory/Ethics Core We recently asked Drs. Jeremy Sugarman and Kevin Weinfurt, Co-chairs of the Regulatory/Ethics Core, to reflect on the first 5 years of the Core as well as on the challenges ahead. The regulatory and ethical landscape for pragmatic clinical trials was not well defined when the Core began 5 years ago, and the Core helped ...
- November 17, 2017: New Video in Living Textbook Explores Data Sharing and Embedded Research As part of an article published in Annals of Internal Medicine, Dr. Greg Simon created a short video in which he describes concerns related to data sharing and embedded research, as well as potential solutions for those concerns. We recently added this video to the Living Textbook chapter on Data Sharing and Embedded Research. In ...
- November 16, 2017: Dr. Eric Larson Discusses the Role of the Health Care System in Successful Pragmatic Trials In this interview, Dr. Eric Larson, Chair of the NIH Collaboratory Health Care Systems Interactions Core, discusses how working effectively with a health care system can maximize the chances of running a successful pragmatic trial. He also notes that creating a research question that aligns with the values and priorities of that health care system can help ...
- New Grand Rounds Podcasts
- Please tell us what you think of the new website!
- NIH Collaboratory policies and guidance documents
- NIH Collaboratory milestone timeline
- Demonstration Projects: Regulatory and Ethics Discussions