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Abstract Details
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Activity Number:
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112
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 1, 2011 : 8:30 AM to 10:20 AM
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Sponsor:
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Biometrics Section
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| Abstract - #300671 |
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Title:
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Challenges in Developing and Validating Biomarkers That Are Treatment Induced: Experiences from an Oncology Phase III Trial
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Author(s):
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Bin Yao*+ and Yining Ye
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Companies:
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Amgen Inc. and Amgen Inc.
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Address:
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MS 24-2-A, Thousand Oaks, CA, 91320 ,
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Keywords:
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oncology ;
biomarker ;
pharmacodynamic ;
validate ;
clinical utility
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Abstract:
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Unlike biomarkers identified at baseline, pharmacodynamic biomarkers are induced after treatment initiation. The utility of this type of biomarkers are often seen in early phase trials as a guide to dosing decisions and toxicity management. The apparent association between a pharmacodynamic biomarker and the clinical outcome may hold promises to identify patients who may or may not benefit from the treatment. However, there are major challenges to overcome in order to establish and to validate the clinical utility of such a biomarker. We will discuss several clinical trial design and analysis issues involving the development of a potential pharmacodynamic biomarker in oncology based on a phase 3 trial.
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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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