JSM 2004 - Toronto

Abstract #300573

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Activity Number: 29
Type: Contributed
Date/Time: Sunday, August 8, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300573
Title: A Case Study of a Group-sequential Response Adaptive Clinical Trial
Author(s): Roy Tamura*+ and Janelle Erickson
Companies: Eli Lilly and Company and Eli Lilly and Company
Address: Lilly Corporate Center, Indianapolis, IN, 46285,
Keywords: adaptive design ; clinical trial ; play-the-winner rule
Abstract:

In most clinical trials, the probability of treatment assignment is determined a priori and is fixed for the duration of the trial. A case study of a one-time group-sequential response adaptive clinical trial will be presented. The focus of the talk will be on the rationale for the adaptive trial, the logistics in implementation, and the choice of an allocation rule. Recent work by Rosenberger et al. (2001) and Hu and Rosenberger (2003) illustrate the trade-off among allocation rules between power and expected number of treatment failures.


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Revised March 2004