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Activity Number:
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152
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Type:
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Roundtables
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Date/Time:
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Monday, August 4, 2008 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302511 |
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Title:
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Innovative Statistical Design Using Biomarkers in Early-Phase Cancer Clinical Trials
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Author(s):
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Ying Lu*+
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Companies:
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University of California, San Francisco
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Address:
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Department of Radiology Box 0946, San Francisco, CA, 94143-0946,
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Keywords:
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Phase I and II trials ; Cancer ; Biomarkers ; Design ; Cytostatic treatment ; Multistage
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Abstract:
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Testing cytostatic cancer treatments using proper biomarkers imposes challenges to the conventional statistical designs of early phase trials. Biomarkers have been used to identify patients most likely to receive the treatment benefits and to evaluate the early sign of efficacy. New statistical designs should integrate these markers into statistical decision process, rather than treat them as the secondary or exploratory endpoints. We will discuss recent research progress and the recommendations from the task force on methodology for the development of innovative cancer therapies. A list of references will be provided.
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