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Activity Number: 592
Type: Topic Contributed
Date/Time: Thursday, August 6, 2009 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305223
Title: A Unified Approach in Data Analysis After Sample Size Is Increased in Adaptive Design Trial
Author(s): Yonghong Gao*+
Companies: FDA
Address: , , 20850,
Keywords: sample size recalculation ; adaptive design
Abstract:

Sample size recalculation is often the main purpose of adaptive design trial. After sample size is increased, special modification in final data analysis is usually needed in order to control the overall type I error rate under the nominal level, and different approaches have been proposed in literature. A unified approach is proposed to combine data from different stages after sample size is increased, and we show that our unified approach covers the popular equal-weigh approach and the down-weigh approach.

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