Watch the video module: Writing a Successful Grant Application

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 J. Weber, PhD, National Center for Complementary and Integrative Health

The National Institutes of Health and the Patient-Centered Outcomes Research Institute (PCORI) are both funders of embedded pragmatic clinical trials (ePCTs). While both organizations share common goals to advance public health, PCORI-funded research requires investigator and patient/community partnership throughout the entirety of the research process from design through results dissemination and implementation. For investigators who are considering submitting an application for an ePCT to the NIH or PCORI, 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.

Watch the video module: Is a Pragmatic Trial Right for Your Research Question?

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.