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Activity Number:
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408
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 1, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309337 |
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Title:
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Challenges in Trial Design for the Next Generation Drug-Eluting Stents
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Author(s):
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Zheng Zhou*+ and Peter Lam
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Companies:
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Boston Scientific Corporation and Boston Scientific Corporation
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Address:
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100 Boston Scientific Way, Malborough, MA, 01752,
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Keywords:
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medical device ; study design ; regulatory submission
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Abstract:
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The presentation is focused on the drug eluting stent (DES) trial and its major hurdle after the first generation DES was approved in the US market. The strategies related to the trial design, the choice of study endpoint and the sample size for future generation DES trials are discussed. The interaction with the FDA statisticians in the approval process is crucial to the success of the IDE submission and a subsequent successful pre-marketing approval (PMA). Case examples are presented to share the experiences of interaction with FDA from the industry perspective.
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