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Activity Number: 27
Type: Contributed
Date/Time: Sunday, August 2, 2009 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #303717
Title: Finding Critical Values with Prefixed Early Stopping Boundaries and Controlled Type I Error for a Two-Stage Adaptive Design
Author(s): Jingjing Chen*+ and Sanat Sarkar and Frank Bretz
Companies: Temple University and Temple University and Norvartis, Switzerland
Address: , Philadelphia, PA, ,
Keywords: adaptive design ; combination test
Abstract:

There are many available statistical methods for adaptive designs, among which the Bauer and Kohne's (1994) combination approach is well known and most widely used. In this article, the Bauer and Kohne's combination approach is generalized in a sense of offering more flexibility. Rather than tying the early rejection and acceptance boundaries together by the combination function, the proposed method allows the choice of the critical value for a combination test to be determined by the prefixed early rejection and acceptance boundaries as well as overall control of Type I error. Explicit formula for determining the critical values based on various combination functions are derived. The proposed method is illustrated using an example in clinical trials.


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