JSM 2005 - Toronto

Abstract #303740

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 483
Type: Contributed
Date/Time: Thursday, August 11, 2005 : 8:30 AM to 10:20 AM
Sponsor: Biometrics Section
Abstract - #303740
Title: A New Interim Monitoring Statistic for Group Sequential Clinical Trials
Author(s): Joshua Tebbs*+ and Barry K. Moser
Companies: Kansas State University and Duke University
Address: 108C Dickens Hall, Manhattan, KS, 66506, United States
Keywords: alpha-spending function ; boundary values ; Data Safety Monitoring Board ; information fraction ; interim analysis
Abstract:

Randomized clinical trials often are performed to determine the efficacy of new drug treatments. In recent years, there has been an interest in using group sequential methods in such trials to allow for the possibility of early stopping when there is clear evidence of an established benefit. The purpose of this paper is to develop a new statistic for monitoring the significance of observed results in a K-stage group sequential test. When K is fixed in advance, the statistic can be used with sequential data collected at equal interim stage sample sizes. When K is not fixed, but the information fractions of the past and present analysis stages are known, the statistic can be formulated through the alpha-spending function for any family of testing procedures.


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