Abstract #300351

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JSM 2003 Abstract #300351
Activity Number: 302
Type: Contributed
Date/Time: Tuesday, August 5, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300351
Title: Analyses of Multiple Survival Endpoints in Confirmatory Randomized Clinical Trials
Author(s): Peiling Yang*+ and Gang Chen and George Y.H. Chi
Companies: Food and Drug Administration and Food and Drug Administration and Food and Drug Administration
Address: 12119 Amber Ridge Circle, Germantown, MD, 20876-3948,
Keywords: multiple testing ; familywise error rate ; survival analysis ; counting processes ; multiple endpoints
Abstract:

In oncologic confirmatory randomized clinical trials survival is often considered a gold efficacy endpoint. A typical survival analysis is logrank test via comparing the overall survival curves between the treatment groups. In some clinical trials, efficacy may alternatively be demonstrated via comparing cumulative survival rates. In that event, both endpoints (overall survival and cumulative survival rates) are considered coprimary endpoints. In this presentation, we propose a method by taking into account of the correlation to analyzing the coprimary endpoints. Comparisons with other existing methods will be discussed.

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