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Activity Number:
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342
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Type:
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Invited
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Date/Time:
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Wednesday, August 6, 2008 : 8:30 AM to 10:20 AM
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Sponsor:
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ENAR
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| Abstract - #300131 |
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Title:
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Statistical Challenges in Vaccine Clinical Studies: An FDA Perspective
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Author(s):
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Amelia D. Horne*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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1401 Rockville Pike, HFM 217, Rockville, MD, 20852,
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Keywords:
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efficacy ; safety ; immunogenicity ; clinical trials
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Abstract:
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This presentation will summarize some of the major statistical issues the FDA must consider in the overall evaluation of preventive vaccines. These issues relate to study design, conduct, and analysis. Ultimately, the FDA must make regulatory decisions regarding licensure and label indications with respect to efficacy, immunogenicity, and safety of the vaccines that are under review. Current issues of interest in evaluating these vaccines will be discussed.
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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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