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8852

The effects of heterogeneity on Simon Phase II clinical trial design operating characteristics

Original Research

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Authors: Christopher N Barnes, Shesh N Rai

Published Date July 2010 Volume 2010:2 Pages 107 - 114
DOI: http://dx.doi.org/10.2147/OAJCT.S10470

Christopher N Barnes1, Shesh N Rai2

1Department of Bioinformatics and Biostatistics, University of Louisville, 2Biostatistics Shared Facility, James Graham Brown Cancer Center, Louisville, Kentucky

Abstract: The homogeneity assumption of a Simon Phase II clinical trial is commonly violated due to excess variation in the response known as response heterogeneity. Using a general framework to model heterogeneity, we investigate its effects on the operating characteristics of the Simon trial design using the standard practice of averaging responses. We show that, under heterogeneity and averaging, the Simon designs have higher than expected errors which may result in false negative and false positive Phase II outcomes.

Keywords: Simon Trial, Phase II, heterogeneity






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