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Abstract Details
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Activity Number:
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454
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 1, 2012 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304494 |
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Title:
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Statistical Applications of Hybrid Cohort Post-Market Surveillance Studies in Medical Devices
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Author(s):
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Hsini Terry Liao*+
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Companies:
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Boston Scientific Corporation
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Address:
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100 Boston Scientific Way, Marlborough, MA, 01752, United States
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Keywords:
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drug-eluting stent ;
post-market surveillance ;
hybrid cohort study ;
cost-effective design
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Abstract:
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A post-market surveillance study is deemed to be requested by which Food and Drug Administration (FDA) can obtain additional safety and effectiveness data for a device after it has been approved through the pre-market approval application (PMA). There are many types of post-market surveillance (PMS). A hybrid cohort study is one of cost-effective designs for a sponsor to provide data which are collected both retrospectively and prospectively. The presentation is to propose strategies of study designs as well as statistical analyses in drug eluting stent studies. In addition, some limitations 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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