JSM 2004 - Toronto

Abstract #300237

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Activity Number: 142
Type: Invited
Date/Time: Monday, August 9, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300237
Title: Adaptive Designs--Design Modifications Beyond Sample-size Reassessment
Author(s): Peter Bauer*+
Companies: University of Vienna
Address: , , , Austria
Keywords: adaptive ; flexible ; interim ; multistage ; clinical
Abstract:

Adaptive (flexible) multistage designs allow for midtrial design modifications based on all type of information from the interim data without compromising on the Type I error rate. The methodology can be derived either from the principle of combining stage-wise test statistics according to a prefixed rule or from the invariance principle for designs adhering to the same conditional error function. The situation is considered when design modifications may have the profound effect of changing the null hypothesis to be tested, e.g., when modifying the set of treatments or doses to be compared or adapting endpoints. The way how to perform multiple inference on the different null hypotheses tested throughout the trial is outlined for different scenarios. The price to be paid for a flexibility which allows to deal with the unexpected is discussed.

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Revised March 2004