This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 217
Type: Invited
Date/Time: Monday, August 2, 2010 : 2:00 PM to 3:50 PM
Sponsor: Statistics in Biopharmaceutical Research Journal
Abstract - #306117
Title: Overcoming the Winner's Curse to Identify Biomarkers with Clinical Relevance in Drug Development
Author(s): Lei Shen*+ and Haoda Fu
Companies: Eli Lilly and Company and Eli Lilly and Company
Address: Lilly Corporate Center, Indianapolis, IN, 46285,
Keywords: pharmacogenomics ; bootstrap ; biomarkers ; tailored therapeutics ; simulations ; multiplicity ; simulations ; multiplicity
Abstract:

When screening a number of markers (or subgroups) for association with clinical endpoints, such as in pharmacogenomic analyses, estimated effect sizes are often used to inform key business decisions. Establishing the clinical relevance of an identified marker is complicated by the Winner's Curse, a form of selection bias induced by multiplicity. Resampling-based methods for bias correction enjoy wide applicability across therapeutic areas with different types of endpoints and analysis models. We present such a method and evaluate it under a number of scenarios. While several methods can reduce bias, the optimal choice in a specific situation may be informed by the underlying profile of effects, such as a small number of strong genetic effects or many weak effects.


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