This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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640
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Type:
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Contributed
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Date/Time:
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Thursday, August 5, 2010 : 8:30 AM to 10:20 AM
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Sponsor:
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Section on Risk Analysis
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Abstract - #307684 |
Title:
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Biomarkers in Clinical Trials in the Development of Biologics and Risk Assessment
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Author(s):
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Samir Lababidi*+
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Companies:
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FDA
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Address:
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1401 Rockville Pike, Rocville, MD, 20850,
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Keywords:
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Biomarker ;
Clinical trial design ;
Genomics ;
Risk Assessment ;
Biologics
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Abstract:
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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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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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