In this video, Dr. Wendy Weber, the Program Officer for the NIH Collaboratory Coordinating Center, provides some expert advice for investigators who are considering submitting an application for a pragmatic clinical trial to the NIH.
“Don’t assume that the study panel is going to understand what pragmatic means. They may have their own completely different definition than you, and it’s important that you get on the same page early on in your application.” —Wendy Weber, PhD, Acting Deputy Director, National Center for Complementary and Integrative Health (NCCIH)
For investigators who are considering submitting an application for an embedded pragmatic clinical trial (ePCT) to the National Institutes of Health (NIH), there are several important aspects to consider. First and foremost, develop and clearly define a clinical research question with a testable hypothesis and then select an experimental design best suited to answering the research question.
The study question drives the research design
For example, efficacy questions (e.g., does the intervention work under ideal settings) are probably best suited to explanatory designs, and questions involving real-world populations (e.g., does the intervention work when implemented in clinical care) are probably best suited to embedded pragmatic designs.
It is important to keep in mind that many reviewers will have little experience with ePCTs and much more experience with traditional explanatory designs. Thus, investigators should clearly describe the study design details and justify the use of a pragmatic trial as opposed to an explanatory trial. In addition, the investigators should define how the trial is “pragmatic,” and clearly describe and justify which elements are (and are not) pragmatic and why making these elements more or less pragmatic improves the ability to test the research hypothesis.
DISCLAIMER: The views expressed in this chapter should not be interpreted as representing the official viewpoint of the U.S. Department of Health and Human Services, the National Institutes of Health, the National Institute on Aging, or the National Center for Complementary and Integrative Health except where noted.