JSM 2005 Online Program

Abstract #303272

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	398
Type:	Contributed
Date/Time:	Wednesday, August 10, 2005 : 10:30 AM to 12:20 PM
Sponsor:	Biopharmaceutical Section
Abstract - #303272
Title:	Trials in Trials: Sample Size Planning
Author(s):	Sue-Jane Wang*+ and Hsien-Ming (James) Hung
Companies:	U.S. Food and Drug Administration and U.S. Food and Drug Administration
Address:	HFD715 PKLN 9B07, Rockville, MD, 20857, United States
Keywords:	subtrial ; design strategy ; sample size ; alpha error ; power
Abstract:	Recently, for assessing the efficacy or safety of medical products in their clinical development program, the pharmaceutical industry has increasingly employed a design strategy that embeds a number of subtrials within a trial. Such a design strategy may be of relevance, for instance, when it is suspected that a certain subgroup of the patients under study may contribute a larger treatment effect. Another instance is that a different study endpoint can be sufficiently studied in a substudy. Undoubtedly, many statistical issues arise with such a strategy. Alpha and power are two important aspects that need critical consideration in sample size planning. In this talk, we investigate the potential utility and limitation of such a design strategy in terms of sample size planning in relation to the effect sizes of the medical product in patient subpopulations and other factors.

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