Additional Resources

CHAPTER SECTIONS

What is a Pragmatic Clinical Trial?


Section 7

Additional Resources

Contributors

Training Resources for Embedded PCTs

The NIH Pragmatic Trials Collaboratory offers practical resources for investigators interested in learning to design, conduct, and disseminate pragmatic clinical trials embedded in healthcare systems. It includes presentations, videos, workshops, and guidance on how to build partnerships with healthcare systems and overcome the challenges of conducting embedded pragmatic research. Visit the Training Resources page to explore these materials.

Rethinking Clinical Trials Grand Rounds and Podcast

An ongoing resource from the NIH Collaboratory is the Rethinking Clinical Trials Grand Rounds webinar series held every Friday at 1:00 pm eastern time. These hour-long webinars with Q&A are presented by experts on a wide range of topics related to pragmatic research. Find all the webinars and related slides in the archive.

The Rethinking Clinical Trials Podcast provides a platform for discussions about interesting and timely issues in the field of pragmatic clinical trials. Featured guests include Grand Rounds speakers, representatives from the NIH Collaboratory Trials, and thought leaders from the NIH Collaboratory and the broader research community.

A special Rethinking Clinical Trials Grand Rounds series on content from the Living Textbook explores key aspects of planning and conducting embedded pragmatic trials, beginning with “Pragmatic Clinical Trials: How Do I Start?” View the webinar below and download the slides.

Table of Contents

In this textbook, we collect information provided by the Core Working Groups, the NIH Collaboratory Trials, and the literature to explore considerations for designing, conducting, and disseminating embedded pragmatic trials. We invite you to navigate through each section sequentially or use the navigation menu to select a topic of interest. A site map in the form of Table of Contents is also available.

Other Resources

Resource Description
Lessons from the NIH Pragmatic Trials Collaboratory
Lessons from the NIA IMPACT Collaboratory
Lessons from the NIH-DoD-VA Pain Management Collaboratory
Ethical challenges of research on usual care
Lessons from IMPACT-AFib, an FDA-Catalyst trial Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial (2020)
Ethical and regulatory issues in pragmatic clinical trials This special issue of Clinical Trials provides background for and links to a series of 12 articles on the ethics and regulatory challenges in pragmatic clinical trials. Each article in this special issue of Clinical Trials describes an issue in detail and, where possible, offers guidance for future pragmatic clinical trials.
Determining Real-World Data’s Fitness for Use and the Role of Reliability This white paper from the Duke-Margolis Center for Health Policy describes how real-world data can generate real-world evidence that more efficiently evaluates the potential benefits or risks of medical products, is more inclusive of broader patient populations, and more reflective of routine clinical and patient self-care.
Research Methods Resources website The NIH Office of Extramural Research has released new clinical trial requirements for grant applications and contract proposals due on or after January 25, 2018. In anticipation of these requirements, the NIH modified the Application Guide and the Review Criteria to address methodological problems common to many clinical trials. As cluster randomized designs are increasingly common in both basic and applied research, the new Application Guide includes links to the new Research Methods Resources website, which provides resources for investigators considering these cluster randomized designs, including lists of NIH webinars, key references, and statements to help investigators prepare sound applications and avoid methodological pitfalls.

Previous Section

SECTIONS

CHAPTER SECTIONS

sections

  1. Why Are We Talking About Pragmatic Trials?
  2. The Embedded Pragmatic Clinical Trial Ecosystem
  3. Differentiating Between Research and Quality Improvement Activities
  4. Pragmatic Elements: An Introduction to PRECIS-2
  5. PRECIS-2 Case Study
  6. Key Considerations for Pragmatic Trials
  7. Additional Resources

ACKNOWLEDGMENTS

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Contributing editors of previous versions of this chapter include Jonathan McCall, Karen Staman, and Liz Wing of the NIH Pragmatic Trials Collaboratory Coordinating Center.

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Version History

Published July 31, 2025

current section :

Additional Resources

  1. Why Are We Talking About Pragmatic Trials?
  2. The Embedded Pragmatic Clinical Trial Ecosystem
  3. Differentiating Between Research and Quality Improvement Activities
  4. Pragmatic Elements: An Introduction to PRECIS-2
  5. PRECIS-2 Case Study
  6. Key Considerations for Pragmatic Trials
  7. Additional Resources

Citation:

O'Brien EC, Weinfurt KP. What is a Pragmatic Clinical Trial?: Additional Resources. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/design/what-is-a-pragmatic-clinical-trial/additional-pct-resourcesv2/. Updated December 3, 2025. DOI: 10.28929/273.