This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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566
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307226 |
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Title:
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Regulatory issues associated with the use of diagnostic test in a screening study
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Author(s):
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Kyunghee Kim Song*+
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Companies:
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FDA/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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screening study ;
diagnostic test ;
bias
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Abstract:
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There has been a great deal of interest in the use of biomarkers to drive regulatory decision for patients with clinical symptoms/diseases. Targeted therapies are often tied to a particular biomarker but how that marker is assessed using a diagnostic device can vary considerably. It is unclear how one then can tie biomarker performance to what counts, what it predicts in terms of survival endpoints for a patient. I will consider different scenarios of diagnostic performance from a statistical point. Finally, I 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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