Statistical Methods for Subgroup Identification in Personalized Medicine
*James J. Chen, National Center for Toxicological Research, FDA Keywords: biomarker, subgroup identification, personalized medicine Personalized medicine applies molecular technologies and statistical methods to identify genomic biomarkers in target patients for assigning more effective therapies and avoiding adverse events. Subgroup identification involves partitioning patients into subgroups defined by sets of biomarkers, where each subgroup corresponds to an optimal treatment. Subgroup identification for treatment selection consists of the three components: 1) biomarker identification, 2) subgroup selection, and 3) performance and clinical utility assessment. Biomarker identification involves developing statistical test procedures to identify a potential set of biomarkers to define patient subgroups. Subgroup selection is to develop a class prediction model to identify patient subgroups for treatment selection. Performance and clinical utility assessment evaluate 1) accuracy of classifiers and 2) power to detect treatment effect in the targeted subgroup. Statistical issues and challenges include experimental design, statistical models and tests to identify predictive biomarkers, classification model development to identify subgroups, classification of imbalanced subgroup sizes, and multiple testing.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC