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Abstract Details
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Activity Number:
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325
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304797 |
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Title:
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Regulatory Issues Associated with Prognostic Biomarker Evaluation
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Author(s):
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Kyunghee 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, United States
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Keywords:
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biomarker ;
prognostic ;
diagnostic test ;
survival outcomes ;
regulatory issues
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Abstract:
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In general, the evaluation of diagnostic test using biomarkers with prognostic claim should include the clinical outcome studies. The clinical outcomes are observed in a follow-up fashion and the clinical performance to support the clinical utility of the device depends on the analysis of these clinical outcomes. However, before making any clinical interpretation, it should be noted that the determination of the biomarker status depends on the diagnostic tests, and there are likely to be false positives and false negatives when imperfect diagnostic tests are used. Therefore, analyzing and interpreting the survival outcomes without considering this possibility introduce bias in the clinical outcome study. In this talk, I will conduct a series of simulation study to address these issues and also discuss 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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