JSM 2005 - Toronto

Abstract #302904

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 57
Type: Topic Contributed
Date/Time: Sunday, August 7, 2005 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #302904
Title: Non-inferiority Testing for Multiple Binary Endpoints
Author(s): Isaac Nuamah*+
Companies: Johnson & Johnson
Address: 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, United States
Keywords: Non-inferiority testing ; binary endpoints ; multiple outcomes
Abstract:

One common objective of clinical trials involving an active control is to determine a new test treatment is not inferior to the active comparator by more than a prespecified, clinically insignificant amount. In the situation where the study has more than one primary endpoint, it may be required that noninferiority on all these multiple endpoints be demonstrated. We present tests of the global null hypothesis of noninferiority when there are multiple binary endpoints with two treatment groups (test versus active control). The results of a simulation study evaluating the empirical power and size of these tests are presented.

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Revised March 2005