American Statistical Association
New York City
Metropolitan Area Chapter

New York State Psychiatric Institute
at Columbia University Medical Center
Biostatistics Seminar



PANEL DISCUSSION:
THE NEW NIMH GUIDELINES FOR R34 PILOT STUDIES

by

H. Blair Simpson, M.D.
Division of Clinical Therapeutics
New York State Psychiatric Institute

Bruce Levin, Ph.D.
Department of Biostatistics
Columbia University

Naihua Duan, Ph.D.
Division of Biostatistics
New York State Psychiatric Institute

Sue Marcus, Ph.D.
Division of Biostatistics
New York State Psychiatric Institute


Abstract

The new NIMH program announcement for Pilot Intervention and Services Research Grants (R34), available online at the following URL: http://grants.nih.gov/grants/guide/pa-files/PAR-09-173.html, provided a new framework for pilot studies such as R34's, with the focus on feasibility/acceptability, instead of the traditional framework that emphasized using pilot studies to obtain preliminary estimates for effect sizes to determine whether to conduct a large R01 trial in the future, and to use the preliminary effect sizes to conduct power analyses to determine the sample size for the R01 trial. This new framework largely followed the recommendations from various biostatisticians, such as Kraemer et al. (2006). We will discuss the implications of this new framework, and strategies for accommodating this framework in grant applications.

Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006 May; 63(5):484-9.


Date: Tuesday, October 26, 2010
Time: 3:00 - 4:00 P.M.
Location: New York State Psychiatric Institute
1051 Riverside Drive
6th Floor Multipurpose Room (6602)
New York, New York
(Directions)

RESERVATIONS ARE NOT REQUIRED

Coffee: 2:45 to 3:00 P.M.
Reception: 4:00 to 4:30 P.M.


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