This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 329
Type: Topic Contributed
Date/Time: Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306350
Title: Sample Size Re-estimation in Crossover Trials
Author(s): Adina Soaita*+ and Byron Jones and Jerry J. Weaver
Companies: Pfizer Inc. and Pfizer Inc. and Pfizer Inc.
Address: 50 Pequot Avenue, New London, CT, CT 06320 ,
Keywords: cross-over ; clinical trial ; sample size re-estimation ; within subject variance ; contrast method ; re-randomization method
Abstract:

Blinded interim analyses in trials that use cross-over designs are becoming more frequent. One of the most popular types of interim is a sample-size re-estimation to ensure that the power of the trial is preserved in situations where there may be some uncertainty as to the size of the within-subject variance when the trial was planned. However, there seems to be little information in the literature on how to do undertake such an analysis. In this presentation we describe how such analyses can be done for cross-over designs with two, three and four periods and for each case provide formulae for the expected bias in a blinded sample-size re-estimation. We also describe an approach based on simulation that can be used when there are missing data or incomplete subjects at the interim.


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