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Abstract Details
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Activity Number:
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66
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 31, 2011 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302102 |
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Title:
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Statistical and Regulatory Issues Associated with Biomarker Evaluation in Monitoring Studies
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Author(s):
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Kyunghee Kim Song*+
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Companies:
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U.S. Food and Drug Administration/CDRH
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Address:
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10903 New Hampshire Ave., Silver Spring, MD, 20993,
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Keywords:
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tumor monitoring ;
biomarker ;
in vitro diagnostic ;
regulatory issues
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Abstract:
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Using biomarkers to drive regulatory decisions in tumor monitoring studies has gained a lot of interest recently. Tumor monitoring using in vitro diagnostic test is to assess the changes in disease status by serial measurements as an aid in the detection of progression or recurrent disease in patients following primary treatment. There are some important statistical issues in evaluating the biomarkers used for monitoring. I will discuss statistical issues as well as regulatory issues associated with study designs in tumor monitoring studies. I will present examples and also would like to address some regulatory concerns.
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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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