Speaker
Wendy Weber, ND, PhD, MPH
Branch Chief, Clinical Research Branch
Division of Extramural Research
National Center for Complementary and Integrative Health (NCCIH)
Topic
Tips for Putting Together a Successful PCT Grant Application
Keywords
Pragmatic clinical trials; Embedded PCTs; Healthcare systems; NIH; Scientific officers; Funding opportunity announcement; Request for application
Key Points
- Investigators interested in developing a compelling grant application for a pragmatic clinical trial (PCT) should consider these tips:
- First, confirm that a PCT is the best study design to answer your research question.
- From the NIH’s 27 Institutes and Centers, find the one that matches your disease area, organ system, or stage of life—and talk with the program official.
- Also find the right funding opportunity announcement (FOA) and tailor your application to address all the FOA-specific instructions and review criteria.
- Do not assume that the study panel is going to understand what pragmatic means; they may have a completely different definition. It is important that you get on the same page early in the application.
- In your application, make sure you justify the research, include pilot data, address potential overlaps, reduce complexity, ensure the aims will advance the field, choose expert personnel for a multidisciplinary team, link data collection and analysis to aims, and justify the use of multiple sites and sample size.
Discussion Themes
For some urgent clinical problems, a PCT may be the only study design that can answer the research question.
Phased awards can be helpful. Determine the key elements of your trial to test in the planning phase. It’s important to “fail quickly”—not in the implementation phase. Applicants should identify milestones in the planning phase that will help convince reviewers their study will be feasible.
Because PCTs take place in changing conditions and real-world healthcare settings, they are not necessarily easier to implement than a traditional efficacy trial.
For more information, visit the Living Textbook’s Developing a Compelling Grant Application.
Tags
#pctGR, @Collaboratory1