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Activity Number: 50
Type: Topic Contributed
Date/Time: Sunday, August 6, 2006 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305646
Title: Issues in the Use of a Composite Endpoint in Megatrials
Author(s): Steven Snapinn*+
Companies: Amgen Inc.
Address: One Amgen Center Drive, Thousand Oaks, CA, 91320,
Keywords:
Abstract:

A megatrial's primary endpoint is often the composite of a number of clinical events. These composite endpoints add complexity to the trial's design and analysis. In this presentation, some of the issues surrounding the use of a composite endpoint---including heterogeneity of the effect of the treatment across components of the endpoint, the appropriate analysis of the components, and considerations for labeling based on a composite endpoint---will be discussed. Several examples of published megatrials will be used.


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Revised April, 2006