JSM 2011 Online Program

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Abstract Details

Activity Number: 610
Type: Topic Contributed
Date/Time: Thursday, August 4, 2011 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #300780
Title: Testing for broad efficacy and efficacy in genomic subgroups using partitioning principle
Author(s): Szu-Yu Tang and Yi Liu*+ and Jason C. Hsu
Companies: The Ohio State University and Millennium: The Takeda Oncology Company and The Ohio State University
Address: , , ,
Keywords: Biomarker ; Personalized medicine
Abstract:

Clinical trials are traditionally designed to prove drug efficacy over the broad patient population. However, some drugs only work for certain subgroups of the entire patient population characterized by its genomic profiles. For example, there is biological reason and preliminary data suggesting breast cancer patients with BRCA mutations might benefit from PARP drugs more. As another example, mutations in P450 metabolizer genes such as 2C19 and 2D6 might affect efficacy of some drugs. Therefore, testing efficacy in one or more genomic subgroups is of interest in addition to testing for broad efficacy. We first show partition testing simplifies the formulation of multiple testing for such studies. We then show partition testing is powerful in executing the analysis, by first comparing weak partitioning test against Hochberg's step-up test, and then improving using the strong partitioning principle


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