Abstract #300418

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JSM 2003 Abstract #300418
Activity Number: 57
Type: Contributed
Date/Time: Sunday, August 3, 2003 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300418
Title: An Overview of Some Strategies for Dealing with Composite Endpoints in Clinical Trials
Author(s): Abdul J. Sankoh*+
Companies: Aventis Pharmaceuticals, Inc.
Address: PO Box 6800, Bridgewater, NJ, 08807-0800,
Keywords: composite endpoint ; multiplicity ; clinical and statistical strategies
Abstract:

For therapeutic areas where the disease manifests itself in a multifaceted manner, drug effectiveness is often characterized by the use of composite endpoints. The use of a composite endpoint could lead to an increase in the overall number of events and hence a reduction in the number of patients needed for the trial. However, there are complications with the interpretation of clinical trial results with a composite endpoint. This is often the case when the composite endpoint result is driven by what is regarded as the softer components of the endpoints or when all components do not trend positively. In addition, testing of the individual or a subset of the components of the endpoint requires a prespecified strategy for analysis and adjustment for multiplicity if the components or subsets of them are to be including in the labeling as being individually influenced. We examine the use of composite endpoints in clinical trials in different disease areas and discuss some clinical and statistical strategies for dealing with multiplicity due to composite endpoint in clinical trials.

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