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Activity Number: 204
Type: Topic Contributed
Date/Time: Monday, August 3, 2009 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304568
Title: Modeling Heterogeneity Across Sites in One-Arm Study
Author(s): Chul H. Ahn*+
Companies: FDA
Address: 1350 Piccard Drive, Rockville, MD, 20850,
Keywords: random effects ; variance components ; heterogeneity ; model expansion ; score test
Abstract:

In one-arm study, the random effects model is often used to model the heterogeneity across the study sites with the assumption of treating the site effects as random. In this case, we are interested in testing whether the variance of random effects is equal to zero (a test for heterogeneity). However, the site effects may be larger than those which can be attributed to random variation. Perhaps, this extra variation can be modeled through the variable defined for each site. In this paper, we propose a method of model expansion to consider this extra variation.

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