, Volume 33, Issue 3, pp 221-228
Date: 11 Jan 2014

Integrating Statistical and Clinical Research Elements in Intervention-Related Grant Applications: Summary From an NIMH Workshop

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Abstract

Objective

The authors summarize points for consideration generated in a National Institute of Mental Health (NIMH) workshop convened to provide an opportunity for reviewers from different disciplines—specifically clinical researchers and statisticians—to discuss how their differing and complementary expertise can be well integrated in the review of intervention-related grant applications.

Methods

A 1-day workshop was convened in October, 2004. The workshop featured panel presentations on key topics followed by interactive discussion. This article summarizes the workshop and subsequent discussions, which centered on topics including weighting the statistics/data analysis elements of an application in the assessment of the application’s overall merit; the level of statistical sophistication appropriate to different stages of research and for different funding mechanisms; some key considerations in the design and analysis portions of applications; appropriate statistical methods for addressing essential questions posed by an application; and the role of the statistician in the application’s development, study conduct, and interpretation and dissemination of results.

Results

A number of key elements crucial to the construction and review of grant applications were identified. It was acknowledged that intervention-related studies unavoidably involve trade-offs. Reviewers are helped when applications acknowledge such trade-offs and provide good rationale for their choices. Clear linkage among the design, aims, hypotheses, and data analysis plan and avoidance of disconnections among these elements also strengthens applications.

Conclusion

The authors identify multiple points to consider when constructing intervention-related grant applications. The points are presented here as questions and do not reflect institute policy or comprise a list of best practices, but rather represent points for consideration.

Views expressed within this article represent those of the authors and are not intended to represent the position of NIMH, NIH, or DHHS. We thank the extramural scientists, public-participant reviewers, and NIMH Review and Program Staff who participated in this NIMH-sponsored workshop for their invaluable input. The authors also acknowledge the ongoing contributions of those who serve in the peer review process; their feedback was instrumental in conceptualizing the workshop and in the preparation of this report.
At the time of submission, Drs. Sherrill, Sommers, Arndt, Greenhouse, Guthrie, Normand, and Woolson disclosed no competing interests. Dr. Nierenberg and Dr. Phillips have provided full disclosure from several public and private sources that are available upon request. Dr. Leon served as a consultant to the FDA, NIMH, MedAvante, and Cyberonics during the past 12 months; he served on Data and Safety Monitoring Boards for Pfizer, Dainippon Sumitomo Pharma America, and Organon. Dr. Shear served on an advisory board for Forest Pharmaceuticals.