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 - #310138 |
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Title:
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Overview of Study Designs for Personalized Medicine
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Author(s):
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Lei Zhu and Sandeep Menon*+ and Siyan Xu
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Companies:
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Boston University and Pfizer Inc. and Boston University
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Keywords:
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Personalized medicine ;
study design ;
biomarker ;
adaptive designs
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Abstract:
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Personalized medicine is a relatively young but rapidly evolving field of clinical research. It involves identifying genetic, genomic, and clinical characteristics that have the potential to accurately predict patient's susceptibility of developing a certain disease and its response to treatment. Personalized medicine is the translation of this knowledge to patient care. However, this "translation" can be very challenging in the phase of limited knowledge of the biomarker and /or appropriate diagnostics. Hence, the appropriate selection of the study design is important to critically determine biomarker performance, reliability and eventually regulatory acceptance. This presentation will discuss various designs including adaptive designs available at our disposal and its merits and limitations.
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Authors who are presenting talks have a * after their name.
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