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Activity Number:
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225
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 5, 2008 : 8:30 AM to 10:20 AM
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Sponsor:
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Section on Statistics in Epidemiology
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| Abstract - #302110 |
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Title:
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Regulatory Issues Related to the Evaluation of Biomarkers in a Clinical Study
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Author(s):
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Kyunghee K. Song*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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1350 Piccard Dr., CDRH, rockville, MD, 20850,
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Keywords:
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biomarker ; diagnostic test ; clinical study ; regulatory issue
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Abstract:
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There has been a great deal of interest in the use of biomarkers to drive clinical decision making for patients with cancer. Targeted therapies are often tied to a particular biomarker but how that marker is assessed using a diagnostic device can vary considerably. Most biomarkers have analytical error associated with the assay. Furthermore, by measuring DNA, gene expression (RNA) or proteins (e.g. via IHC) we are not capturing the target in a comparable manner. 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 levels of diagnostic performance and examine how this would impact the statistical evaluation of clinical outcome measures. 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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