Abstract Details
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Activity Number:
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631
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 8, 2013 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308292 |
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Title:
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Recent Advances in Design and Methodology in Psychiatric Clinical Trials
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Author(s):
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Peiling Yang*+
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Companies:
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Food and Drug Administration
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Keywords:
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adaptive design ;
placebo response ;
dose response exploration ;
multiple comparison procedure ;
missing data ;
psychiatric clinical trial
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Abstract:
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In this talk, I will illustrate trial design and methodology that have received increasing attention in recent psychiatric drug development and comment on the pros and cons from a regulatory perspective. Examples include application of adaptive design with the associated methodology, re-randomization to reduce placebo response, suggestions to mitigate dropouts, dose response exploration, and the utility of multiple comparison procedures.
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Authors who are presenting talks have a * after their name.
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