Abstract #301704

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JSM 2003 Abstract #301704
Activity Number: 470
Type: Contributed
Date/Time: Thursday, August 7, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract - #301704
Title: Alpha Allocation and Interpretation of Composite Endpoints in Clinical Trials
Author(s): Lemuel A. Moye*+
Companies: University of Texas
Address: PO Box 20186, Houston, TX, 77225-0186,
Keywords: clinical trials ; composite endpoints ; alpha allocation ; interpretation
Abstract:

Composite endpoints are commonly used to assess the effects of a randomly allocated intervention in a clinical trial. The prospective anticipation of dependency between statistical hypothesis tests in the analysis of these composite endpoints can improve the trial's power to identify statistically significant effects of therapy. However, there is no commonly accepted procedure to take advantage of this dependency when the prospectively declared endpoints in the clinical trial are composite. The application of an argument based on conditional probability provides a tractable recursive relationship that incorporates dependency between dependent statistical hypothesis tests. This relationship permits the assignment of a priori hypothesis test-specific alpha levels to each of a component endpoint and its constituent endpoints in a clinical trial in such a way that the dependent nature of the relationships between the endpoints is taken into account and the familywise Type I error rate is preserved. Several examples are provided that demonstrate the utility of this procedure, including the current design of a cardiology clinical trial.

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