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Activity Number:
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481
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Type:
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Roundtables
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Date/Time:
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Wednesday, August 5, 2009 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305236 |
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Title:
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Retrospective Studies of Biomarkers: How Can They Improve Our Understanding of Drug Use?
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Author(s):
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Estelle Russek-Cohen*+
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Companies:
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FDA
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Address:
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1350 Piccard Drive, HFZ-550, Rockville, MD, 20850,
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Keywords:
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Biomarkers ; Personalized Medicine ; Drug by Marker Interactions ; Clinical trials
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Abstract:
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I am in the Center for Devices and Radiological Health where I oversee the statistical reviews for many "biomarker" submissions coming to FDA. Some come in with the proposed intended use of improving treatment choice for patients. In December 2008, the Center for Drugs held an open public panel on the use of retrospective samples to inform a drug label. I thought the comments of the panel members would be interesting to share and getting feedback from others would be interesting. Advancing personalized medicine continues to be a challenge and there are many open issues in which statisticians have a role to play. The panel had 4 prominent statisticians suggesting that FDA realizes how important study design and analysis is in this arena. This is intended to be an informal dialog and reflects my personal interest in this topic. It does not necessarily reflect the views of the agency.
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