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ARCHIVED – What is a Pragmatic Clinical Trial
Section 7
Additional Resources – ARCHIVED
Training Resources for Embedded PCTs
The NIH Collaboratory offers practical resources for investigators interested in learning to design, conduct, and disseminate ePCTs. It includes presentations, videos, workshops, and guidance on how to build partnerships with health systems and overcome the challenges of conducting embedded pragmatic research. Visit the Training Resources page to explore these materials.
PCT Grand Rounds Presentations and Podcasts
An ongoing resource from the Collaboratory is the PCT Grand Rounds series held every Friday from 1-2 pm (ET). These are hour-long webinars with Q&A presented by experts on a wide range of topics related to ePCTs. Find all the webinars and related slides in the archive. Occasional Grand Rounds podcasts are also available that provide extra content from speakers through conversations with Collaboratory moderators about interesting and timely issues around ePCTs.
A special Grand Rounds series on content from the Living Textbook explores key aspects of planning and conducting embedded PCTs, beginning with Pragmatic Clinical Trials: How Do I Start? View the webinar below and download the slides (PDF).
Table of Contents
In this textbook, we collect information provided by the NIH Collaboratory Cores, NIH Collaboratory Trials, and the literature to explore considerations for designing, conducting, and disseminating ePCTs. 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 |
| Journal articles | |
| Articles on ethical challenges facing research on usual care | |
| Garcia et al. Clin Trials, 2019 | Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial |
| Tuzzio et al. Healthc (Amst), 2019 | Pragmatic clinical trials offer unique opportunities for disseminating, implementing, and sustaining evidence-based practices into clinical care: Proceedings of a workshop |
| Weinfurt et al. BMC Med Res Method, 2017 | Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory |
| Sherman et al. N Engl J Med, 2016 | Real-World Evidence - What Is It and What Can It Tell Us? |
| Ethical and Regulatory Issues in Pragmatic Clinical Trials: Special Issue of Clinical Trials | This document provides background and links to a series of 12 articles on the ethics and regulatory challenges in pragmatic clinical trials. Each article in the special issue of Clinical Trials describes an issue in detail (e.g., privacy, informed consent) and, where possible, attempts to provide guidance for future pragmatic clinical trials. |
| White papers | |
| 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. |
| Lessons Learned from the NIH Health Care Systems Research Collaboratory Trials | This document presents problems and solutions for PCT initiation and implementation that were developed by drawing on the trial-specific experiences of the NIH Collaboratory Trials. |
| Websites |
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| Research Methods Resources website | The National Institutes of Health (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 new requirements, the NIH modified the Application Guide and the Review Criteria to address methodological problems common to many clinical trials. As group- or cluster-randomization 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 group- or cluster-randomized designs, including lists of NIH webinars, key references, and statements to help investigators prepare sound applications and avoid methodological pitfalls. |
SECTIONS
sections
- Why Are We Talking About Pragmatic Trials? – ARCHIVED
- The Embedded Pragmatic Clinical Trial Ecosystem – ARCHIVED
- Differentiating Between RCTs, PCTs, and Quality Improvement Activities – ARCHIVED
- Pragmatic Elements: An Introduction to PRECIS-2- ARCHIVED
- PRECIS-2 Case Study – ARCHIVED
- Key Considerations for PCTs – ARCHIVED
- Additional Resources – ARCHIVED
current section : Additional Resources – ARCHIVED
- Why Are We Talking About Pragmatic Trials? – ARCHIVED
- The Embedded Pragmatic Clinical Trial Ecosystem – ARCHIVED
- Differentiating Between RCTs, PCTs, and Quality Improvement Activities – ARCHIVED
- Pragmatic Elements: An Introduction to PRECIS-2- ARCHIVED
- PRECIS-2 Case Study – ARCHIVED
- Key Considerations for PCTs – ARCHIVED
- Additional Resources – ARCHIVED