This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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445
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Type:
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Invited
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Date/Time:
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Wednesday, August 4, 2010 : 8:30 AM to 10:20 AM
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Sponsor:
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Section on Statistical Consulting
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| Abstract - #308717 |
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Title:
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Evaluating Diagnostics Hypotheses in Proof-of-Concept Clinical Trials
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Author(s):
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Jane Fridlyand*+
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Companies:
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Genentech
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Address:
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1 DNA way, South San Francisco, CA, 94080,
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Keywords:
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biomarker ;
molecular profiling ;
diagnostics ;
personalized medicine ;
clinical trials ;
proof of concept
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Abstract:
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Much of the current medical practice is based on one-size-fits-all drugs paradigm. However, as the slowdown in the number of the new drug approvals demonstrates, this philosophy is no longer viable. The FDA Critical Path Initiative calls for focus on personalized medicine approaches. In this talk we discuss approaches to evaluating diagnostics hypotheses during Proof of Concept Phase of drug development and designing next phase confirmatory studies. We demonstrate that with the proposed design, we are able to maximize the probability of technical success of the development program without sacrificing its speed.
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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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