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Abstract Details

Activity Number: 278
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2012 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #305090
Title: Testing Efficacy for Multiple Endpoints in Clinical Trials That Allow Sample Size Adaptation
Author(s): Yi Liu*+ and Mingxiu Hu
Companies: Millennium: The Takeda Oncology Company and Millennium Pharmaceuticals, Inc.
Address: 35 Landsdowne Street, Cambridge, MA, 02139, United States
Keywords: sample size re-estimation ; FWER

A lot of sample size re-estimation methods have been proposed and discussed in the recent literature. Implemented with care, these designs can gain power over the traditional fixed sample size or the group sequential design while still preserving the Type I error rate. However, most of them are restricted to testing a single hypothesis. In this paper, we propose designs that apply certain sample size adaptation rules at the interim analysis in a group sequential setting that aims to claim efficacy for multiple endpoints. A theoretical proof of the strong control of overall Familywise Error Rate (FWER) is provided. Power comparisons with the traditional group sequential method with multiple endpoints are performed and discussed.

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