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

Received December 12, 2007; revised February 29 and April 15, 2008; accepted May 20, 2008. Dr. Sherrill is affiliated with Division of Services and Intervention Research (DSIR) at NIMH; Dr. Sommers is affiliated with the Division of Extramural Activities at the NIMH; Dr. Nierenberg is affiliated with the Department of Psychiatry at MGH; Dr. Leon is affiliated with the Department of Psychiatry at Weill Medical College of Cornell University; Dr. Arndt is affiliated with the Iowa Consortium for Substance Abuse Research at University of Iowa Hospitals and Clinics; Dr. Bandeen-Roche is affiliated with the Department of Biostatistics at Johns Hopkins Bloomberg School of Public Health; Dr. Greenhouse is affiliated with the Department of Statistics at Carnegie Mellon; Dr. Guthrie is Professor Emeritus of Biostatistics at UCLA; Dr. Normand is affiliated with Harvard Medical School; Dr. Phillips is affiliated with the Department of Psychiatry & Human Behavior at Brown University; Dr. Shear is affiliated with the School of Social Work at Columbia University; Dr. Woolson is affiliated with the Department of Psychiatry/Biostatistics at Medical University of South Carolina. Address correspondence to David I. Sommers, National Institute of Mental Health, Division of Extramural Activities, 6001 Executive Boulevard, Room 6144, Bethesda, MD 20892; dsommers{at}mail.nih.gov (e-mail).

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.

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