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Activity Number: 483 - Multiplicity
Type: Contributed
Date/Time: Wednesday, August 1, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #327131 Presentation
Title: Composite Endpoints in Clinical Trials with Multiple Correlated Dichotomous Outcomes
Author(s): Boris Zaslavsky*
Companies: FDA/CBER
Keywords: Composite endpoints, Non-inferiority, Hypotheses testing

The author considers studies with multiple correlated dichotomous outcomes. The primary difficulties with composite endpoints are that different endpoints may have different clinical importance and that higher-frequency variables may overwhelm effects of smaller, but equally important, primary outcomes. To compensate for these inconsistencies, each type of event is weighted, and the total number of weighted events is counted. To reflect the mutual dependency of primary endpoints and to make the weighting method effective in small clinical trials, we apply the test of non-inferiority to the calculation of weighting parameters. The composite endpoints can be used to test hypotheses of superiority in single-arm and two-arm clinical trials. We illustrate this technique with an example. The approach may be used to reduce the sample size of clinical trials with multiple dependent primary endpoints.

Authors who are presenting talks have a * after their name.

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