JSM 2004 - Toronto

Abstract #300856

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Activity Number: 307
Type: Contributed
Date/Time: Wednesday, August 11, 2004 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #300856
Title: A Stopping Plan for a Bioequivalence Study
Author(s): Shu-Ping Lan*+
Companies: Pfizer Inc.
Address: 50 Pequot Ave., New London, 06320,
Keywords: adaptive design ; group sequential methods ; bioequivalence study ; stopping rules
Abstract:

In designing bioequivalence studies, if the possibility of early termination to claim success is desirable, interim analyses based on group sequential methods can be planned and pre-specified in the protocol. Reasons for the consideration of early termination include unstable estimate of the variance, larger-than-usual sample size required, difficulty in recruitment, ethical reasons, etc. In addition, at the interim analyses, considerations for stopping the trial due to futility can be evaluated based on conditional power calculations. Stopping the trial for futility is at the sponsor's risk and hence need not be pre-specified in the protocol. An example is given for a stopping plan in designing a bioequivalence study, which uses the extension of group sequential methods and conditional power calculations. The sequential boundaries were transformed into "sequential confidence levels," which can be used as the criteria for boundary-crossing in the interim analyses. We also extended the concepts of conditional power to provide evaluations of stopping due to futility.

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