JSM 2004 - Toronto

Abstract #300945

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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 - #300945
Title: Toward a New Way of Thinking about Power and Sample Size
Author(s): John Johnson*+
Companies: Rho, Inc
Address: 100 Eastowne Dr., Chapel Hill, NC, 27514,
Keywords: clinical trials ; power and sample size ; group sequential
Abstract:

Recent advances in the use of the group sequential clinical trials and the difficult questions they raise are going to require us to rethink power and sample size. No longer can we categorize errors as Type I or II, set a probability for each, and solve for a number or even a set of boundaries. For example, NonStop methodology, which is an application of group sequential to the conduct of clinical trials, assumes that there will be no Type I error. For otherwise, we would stop, declare efficacy, and file an NDA. Therefore, the role of Type I error probability is muddled. We refine the roles of alpha and beta in creating group sequential designs and clarify their interpretation. Then we explore a richer set of possibilities of how a group sequential trial can go wrong. Finally, we discuss the implications on the design of such a trial.

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Revised March 2004