NIH Collaboratory Rethinking Clinical Trials – The Living Textbook

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.

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What is a

pragmatic clinical trial?


Engaging stakeholders

and building partnerships to ensure a successful trial


What is the

NIH Collaboratory?

NIH Collaboratory

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:

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.

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Upcoming Learning Opportunities

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  • February 15, 2018: Timely Tips from Demonstration Project Principal Investigators The NIH Collaboratory will soon welcome a new group of Demonstration Projects and guide them through the piloting and implementation phases of their embedded pragmatic clinical trials (ePCTs). We asked three seasoned principal investigators—Drs. Laura Dember, MD (TiME), Lynn DeBar, PhD (PPACT), and Jerry Jarvik, MD, MPH (LIRE)­—to share tips and advice for investigators who ...
  • February 14, 2018: Grand Rounds Podcasts Now Available on iTunes The NIH Collaboratory is pleased to announce that Grand Rounds podcasts are now available on iTunes. These podcasts aim to give listeners a deeper understanding of topics discussed during Grand Rounds presentations through interviews with the speakers. Topics covered in past episodes include the IMPACT-Afib trial and the role of Sentinel, data and safety monitoring ...
  • February 7, 2018: In New Video, Drs. Susan Huang and Gloria Coronado Give Advice to Pragmatic Trial Investigators In the spring of 2018, the NIH Collaboratory will be welcoming a new set of Demonstration Projects and will help shepherd the new pragmatic trials through the piloting and implementation phases of their studies. In a new video in the Living Textbook, two of our seasoned principal investigators—Drs. Susan Huang and Gloria Coronado—give advice to ...

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Promoting PRAGMATIC RESEARCH to increase the availability of high-quality medical evidence and IMPROVE patient care.


NIH Collaboratory Rethinking Clinical Trials – The Living Textbook: NIH Collaboratory Rethinking Clinical Trials – The Living Textbook. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: Updated February 16, 2018.