JSM 2011 Online Program

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Abstract Details

Activity Number: 112
Type: Topic Contributed
Date/Time: Monday, August 1, 2011 : 8:30 AM to 10:20 AM
Sponsor: Biometrics Section
Abstract - #300614
Title: Statistical Challenges in Genetic Biomarker Treatment Association with Clinical Outcomes: Experience from an Infectious Disease Phase II and Phase III Trials
Author(s): Peggy H. Wong*+ and Navdeep Boparai
Companies: Merck & Co., Inc. and Merck & Co., Inc.
Address: P.O. Box 2000, RY34-A316, Rahway, NJ, 07901, US
Keywords: Pharmacogenetics ; IL28B SNP ; Phase II ; feasibility
Abstract:

As the cost of genomic technology decreases, there has been a corresponding increase in the number of studies attempting to leverage genetics to assign treatments or dose. The results of these studies from literature, academic partnerships or internal studies can influence drug development real time. One challenge is to assess the feasibility and cost of qualifying that reported biomarker in ongoing phase II and III trials, or to define a biomarker in phase II for use in phase III. There are different challenges in using the same clinical trials for continued discovery. An infectious disease example will be used to drive the discussion. In this particular example, one IL28B SNP (rs12979860 on chromosome 19) was associated with 2-fold difference in sustained viral response in all patients with the CC genotype after administration of peg-IFN+RBV treatment in several studies (Fellay, 2010). The feasibility of incorporating that genetic research into the phase II and III studies based on assumptions on frequency of genetic variant, amount of consented population and expected effect. In addition, the results of the statistical testing of the genotypic association will be presen


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