JSM 2005 - Toronto

Abstract #304277

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 361
Type: Contributed
Date/Time: Wednesday, August 10, 2005 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #304277
Title: Flexible Multi-stage Study Design for Single-arm, Phase-II Clinical Trials
Author(s): Muhammad Jalaluddin*+ and Enayet Talukder
Companies: Pfizer, Inc. and Pfizer, Inc.
Address: 50 Pequot Avenue, MS 6025-A3257, New London, CT, 06320, United States
Keywords: Clinical trials ; flexible design ; two-stage design ; sample size
Abstract:

Two-stage designs are commonly used in single-arm, phase-II clinical trials. These designs require a fixed number of subjects in stages one and two. However, in multicenter trials, it is difficult to have an exact number of evaluable subjects as planned. In such situations, adjustments to decision rules are needed to preserve the operating characteristic of the design. Therefore, an information-based, flexible, two-stage design approach is introduced. Applications of this approach under different setups are discussed.

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Revised March 2005