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Abstract Details
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Activity Number:
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531
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Type:
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Roundtables
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Date/Time:
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Wednesday, August 3, 2011 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301437 |
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Title:
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Adaptive Designs in a Confirmatory Setting
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Author(s):
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Jeff Maca*+
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Companies:
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Novartis
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Address:
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One Health Plaza, East Hanover, NJ, , 07936-1080
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Keywords:
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Adaptive designs ;
Clinical Trials ;
Confirmatory Studies ;
Sample Size reestimation
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Abstract:
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Over the last few years, there has been much research, and now much implementation of adaptive designs in clinical trials. With the release of the FDA guidance document, many people are implementing, or planning on implementing such clinical trial designs. Now would be a good opportunity to discuss what has been learned and what issues which must be addressed to properly conduct these types of study designs.
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Authors who are presenting talks have a * after their name.
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