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Abstract Details
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Activity Number:
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457
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302127 |
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Title:
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Prediction Biomarkers for Safety or Efficacy
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Author(s):
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Estelle Russek-Cohen*+ and Rong Tang
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Companies:
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U.S. Food and Drug Administration and U.S. Food and Drug Administration
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Address:
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Center for Biologics, Rockville, MD, 20852,
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Keywords:
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Prediction Biomarker ;
safety ;
efficacy ;
study design
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Abstract:
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Most of the statistical literature regarding evaluation of prediction biomarkers that identify patients for a particular therapy focus on efficacy of the therapy. However, we now see markers (such as those assessed using in vitro assays) that are used to identify patients at greater risk for an adverse event associated with the use of the therapy. The study designs and endpoints for these kinds of studies are apt to be different from those evaluating efficacy and may also vary depending on whether the therapy is already in use. We will present an overview of some of the design and analysis considerations, contrasting study designs for prediction biomarkers used for evaluating efficacy versus those used for addressing safety of a therapeutic.
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