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Abstract Details
Activity Number:
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19
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 31, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #301686 |
Title:
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Good Statistical Practice for Medical Device Trial Submission
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Author(s):
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Huyuan Yang*+ and Matthew Rousseau and Peter Lam
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Companies:
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Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation
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Address:
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Boston Scientific Way, Marlborough, MA, 01752, USA
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Keywords:
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IDE submission ;
statistical practice ;
Bayesian approach
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Abstract:
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The presentation will focus on the key statistical components of a good IDE submission and on the best practice. This talk will focus on statistical issues include the assumption used in sample size calculation, missing data sensitivity analyses, and pooling strategies. Case examples of Frequentist and Bayesian approaches will be discussed to illustrate the good statistical practice.
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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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