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Activity Number: 260
Type: Invited
Date/Time: Tuesday, July 31, 2007 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract - #308082
Title: Multicenter Clinical Trials with Binary Outcomes and Random Effects for Centers: Sample Size Determination
Author(s): Kathryn Chaloner*+
Companies: The University of Iowa
Address: Dept of Biotatistics, Dept of Statistics and Actuarial Science, Iowa City, IA, 52242,
Keywords: Bayesian ; Clinical trial ; Sample Size
Abstract:

The question of choosing a sample size for a multi-center clinical trial where the analysis involves a binary response will be reviewed. A Bayesian hierarchical model is assumed. Centers are assumed to be exchangeable and so random effects for center are incorporated into the statistical analysis plan. Enrollment at each center is anticipated to be different, with some centers having much larger sample sizes than others. Of interest is not only to determine overall efficacy of an intervention, but also to require each center to demonstrate sufficient evidence of efficacy. Examples will be given, along with simulations to examine the properties of different designs. This work is joint with M. Katherine Cowles, Emine O. Bayman, Qian Cicci Shi and Lixun Zhang (University of Iowa).


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Revised September, 2007