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Writing a Grant: Challenges in Clinical Trial Design and Important Statistical Considerations

09:00 - 12:00, Brickell South, Terrace Level

Download the Small Group Exercise Prompts


Cynthia Long (1), Laura Lee Johnson (2) Steve Simon (3), Rachael Rivard (4)


(1): Palmer Center for Chiropractic Research, United States

(2):  National Institutes of Health (NIH) National Center for Complementary and Alternative Medicine (NCCAM), United States

(3): P. Mean Consulting, United States

(4): Penny George Institute for Health and Healing, Allina Health, United States



This workshop is intended to help participants in their grant writing efforts with an emphasis on addressing important issues pertaining to clinical trial design, statistical considerations and how to present a study proposal to grant, protocol, and manuscript reviewers. The introduction will discuss how complementary alternative medicine (CAM) and integrative medicine (IM) trials are and are not different from other medical trials and the obstacles that these trials face. Though alternative study designs will be discussed, the focus will be on randomized, controlled clinical trials and the elements in designing such studies. We will identify those elements of the study design that grant reviewers focus on and expect to be in a grant proposal. We will also discuss statistical considerations such as sample size and identifying an appropriate statistical consultant for grant proposals. A practicum conducted in small groups will be focused on refining clinical trial designs submitted by former participants and/or proposed by workshop teachers. This workshop will help researchers, in particular research trainees, fellows and junior faculty, in their grant writing efforts with an emphasis on important issues pertaining to a statistician's role on collaborating in grant writing, how to find and effectively collaborate with a statistician and data manager, critical issues that need to be addressed, and what reviewers look for in the research strategy section.