Abstract #300992

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JSM 2003 Abstract #300992
Activity Number: 135
Type: Luncheons
Date/Time: Monday, August 4, 2003 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300992
Title: Impact of Secondary Endpoint Multiplicity Issues on Drug Development Programs - THIS LUNCHEON IS SOLD OUT
Author(s): Thomas P. Capizzi*+
Companies: Merck Research Laboratories
Address: PO Box 2000 Ry34-A320, Rahway, NJ, 07065,
Keywords: multiplicity adjustment ; secondary endpoints ; clinical trials ; regulatory guidelines
Abstract:

Dealing with multiplicity issues that arise in clinical trials with multiple primary endpoints has been a topic of much discussion and research. However, recently regulatory agencies (for example, CPMP points to consider document on multiplicity) and others in the statistical community have suggested that there is also a need to consider multiplicity adjustments for secondary endpoints, particularly for those that the sponsor desires to describe in product labeling. This will be a forum for discussion of participants' recent experiences in dealing with this controversial issue, which will lead to a better understanding of the issue and sensible strategies for dealing with it.

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Revised March 2003