Abstract Details
Activity Number:
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46
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Type:
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Invited
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Date/Time:
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Sunday, August 3, 2014 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #310699
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View Presentation
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Title:
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Post Marketing Commitments: Study Designs and Their Implications for DMCs
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Author(s):
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Susan S. Ellenberg*+
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Companies:
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University of Pennsylvania
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Keywords:
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data monitoring committee ;
post-marketing commitment ;
clinical trial ;
product safety
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Abstract:
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Studies performed to fulfill post-marketing commitments range from single-arm studies performed simply to collect more information on drug effects, to randomized double-blind studies to evaluate long-term clinical effects of drugs receiving accelerated approval, to single-arm or randomized studies intended to further assess a potential safety signal identified in pre-market studies. Each type of study has different implications for data monitoring. Not all post-marketing studies will require a formal, independent DMC. Studies performed specifically to assess a potential safety signal, or where the outcome being evaluated is mortality or another serious event, will most likely require such oversight.
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Authors who are presenting talks have a * after their name.
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