What is a Pragmatic Clinical Trial
Karen Staman, MS
Jonathan McCall, MS
Liz Wing, MA
|Ethical and Regulatory Issues in Pragmatic Clinical Trials: Special Issue of Clinical Trials||This page 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.|
|Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory||This article contains lessons learned from the first four years of the Collaboratory and experiences with the Demonstration Projects. The authors highlight some of the challenges encountered and solutions developed and discuss remaining barriers and opportunities for large-scale evidence generation using pragmatic clinical trials.|
|Introduction to Pragmatic Clinical Trials: How Pragmatic Clinical Trials Bridge the Gap Between Research and Care||This presentation, created by the NIH Collaboratory’s Health Care Systems Interactions Core, was published as supplemental material to an article appearing in BMJ. Provided here courtesy of Karin Johnson, PhD.|
|Learning Healthcare Systems Living Textbook Chapter||Learning healthcare systems are characterized by a number of core attributes; particularly important is a consistent emphasis on a collaborative approach that shares data and insights across boundaries to drive better, more efficient medical practice and patient care. Read the full chapter for more information.|
|Lessons Learned from the NIH Health Care Systems Research Collaboratory Demonstration Projects||This document presents problems and solutions for PCT initiation and implementation that were developed by drawing on the trial-specific experiences of the Collaboratory Demonstration Projects.|
In May 2017, the NIH Collaboratory conducted a series of interviews with leaders of the Core Working Groups to hear their reflections on the accomplishments of the first 5 years of their Core and the challenges ahead.
In April 2015, the NIH Collaboratory conducted a series of interviews with the principal investigators of its first round of pragmatic clinical trial Demonstration Projects. These projects completed a pilot phase before scaling up to full implementation in 2014-2015. The purpose of the interviews was to share challenges and lessons learned that may help future pragmatic trials.
|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.