Abstract Details
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Activity Number:
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130
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Type:
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Contributed
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Date/Time:
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Monday, August 5, 2013 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #310159 |
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Title:
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Personalized Medicine in Oncology: A Statistical Perspective
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Author(s):
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Cheng Rong*+
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Companies:
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Amgen
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Keywords:
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Personalized Medicine ;
Oncology Clinical Trials ;
Biomarker ;
Predictive Value ;
Testing Validation
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Abstract:
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Personalized Medicine in Oncology has been focusing mainly in the research of biomarkers where many target therapies are now standard of care. The process of discovery, confirmation and validation for biomarkers has brought new statistical challenges. Personalized Medicine eyes on predictive biomarkers yet it is often very difficult to differentiate from prognostic ones. In this presentation I will give a statistical perspective on some common issues facing statisticians including: 1) Type of biomarkers and respective values 2) Reliability of biomarkers: how do we know they are predictive? 3) Design of biomarker confirmatory phase 3 trials in Oncology 4) Statistical challenges in analyzing biomarker P3 data 5) Issues on validating biomarker testing kit
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Authors who are presenting talks have a * after their name.
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