Abstract Details
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Activity Number:
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637
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 7, 2014 : 10:30 AM to 12:20 PM
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Sponsor:
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Section on Medical Devices and Diagnostics
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Abstract #312682
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View Presentation
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Title:
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Statistical Issues in Developing Predictive Biomarkers in Drug Clinical Trials
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Author(s):
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Nusrat Rabbee*+
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Companies:
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Keywords:
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Genomic Biomarker ;
Biomarker ;
Molecular Diagnostic ;
Companion DIagnostics ;
clinical trial design ;
Predictive Biomarker
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Abstract:
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A survey of methods for developing predictive biomarkers in clinical trials for drugs. The development of companion diagnostics for next-generation drugs is drawing tremendous amount of investment today. Numerous statistical methods and software are being used to choose between different designs for Phase II and Phase III trials. This talk will focus on methods currently being used complex scenarios where a drug and a predictive biomarker are being codeveloped. References to relevant designs and software will be provided where appropriate.
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Authors who are presenting talks have a * after their name.
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