JSM 2004 Online Program

Abstract #301390

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Activity Number:	338
Type:	Contributed
Date/Time:	Wednesday, August 11, 2004 : 10:30 AM to 12:20 PM
Sponsor:	Biopharmaceutical Section
Abstract - #301390
Title:	Uncertainty in Planning Sample Size of Phase III Trial Based on Phase II Data
Author(s):	Sue-Jane Wang*+ and H.M. James Hung
Companies:	U.S. Food and Drug Administration and U.S. Food and Drug Administration
Address:	5600 Fishers Lane, Rockville, MD, 20857,
Keywords:	uncertainty ; sample size ; phase II ; phase III
Abstract:	A recent informal survey suggested that the success rate of phase III clinical trials is low. Many research efforts are taking place to explore possible causes. Traditionally, phase II trials are relatively small and can be expected to result in a large degree of uncertainty in the estimates based on which phase III trials are planned. We investigate the impact of various treatment effect estimates or strategies on the sample size planning for phase III trials.

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