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

Abstract Details

Activity Number: 640
Type: Contributed
Date/Time: Thursday, August 5, 2010 : 8:30 AM to 10:20 AM
Sponsor: Section on Risk Analysis
Abstract - #307684
Title: Biomarkers in Clinical Trials in the Development of Biologics and Risk Assessment
Author(s): Samir Lababidi*+
Companies: FDA
Address: 1401 Rockville Pike, Rocville, MD, 20850,
Keywords: Biomarker ; Clinical trial design ; Genomics ; Risk Assessment ; Biologics
Abstract:

With so many diseases being heterogeneous in molecular pathogenesis and treatment responsiveness, it takes large clinical trials to identify small average treatment benefits for heterogeneous groups of patients. Biologics that demonstrate effectiveness in such trials may subsequently be used broadly, resulting in ineffective treatment of many patients. New genomic technologies can provide powerful tools for the selection of patients likely to benefit from a therapeutic without unacceptable adverse events. In this talk we attempt to provide guidance on the design of clinical trials for evaluating the clinical utility and robustness of genomic biomarkers in the development of biologics and safety studies for risk assessment.


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