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Abstract Details
Activity Number:
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536
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Type:
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Roundtables
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Date/Time:
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Wednesday, August 3, 2011 : 12:30 PM to 1:50 PM
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Sponsor:
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Section on Health Policy Statistics
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Abstract - #302041 |
Title:
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Relative Efficiency for Various Designs of Biomarker-Directed Clinical Trials
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Author(s):
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Xiaofei Wang and Stephen George*+
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Companies:
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Duke University and Duke University
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Address:
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Medical Center, Durham, NC, 27710,
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Keywords:
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Biomarker ;
Biomarker-directed study ;
Clinical trials ;
Personalized medicine ;
Relative efficiency ;
Target agents
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Abstract:
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Biomarkers play an important role in disease diagnosis, prognostic stratification and prediction of outcome, and ultimately in personalized medicine. New drugs are increasingly being developed to target patient subgroups with unique molecular signatures. The efficacy and safety of targeted agents and the predictive accuracy of the associated biomarker need to be evaluated in clinical trials. This round table will focus on the statistical and cost issues in the design and analysis of biomarker-directed clinical trials for evaluating biomarker-directed treatment. Common designs in biomarker-directed clinical trials, biomarker-targeted designs, biomarker-stratified designs and biomarker-strategy designs, will be reviewed. The relative efficiency in conducting clinical trials using these designs will be discussed in term of the number of required patients, study time and cost.
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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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