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Abstract Details
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Activity Number:
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325
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305598 |
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Title:
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Subgroup Gender Analysis in Medical Device Trials
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Author(s):
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Songtao Jiang*+ and Peter Lam and Hong Wang and Milan Seth
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Companies:
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Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation and 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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sex ;
gender ;
medical device ;
statistical analysis ;
FDA guideline
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Abstract:
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In clinical studies, gender is known factor which could have impact on man and woman differently. Often time statistical analyses for gender differences are required in clinical studies. The recent FDA draft guideline on gender difference will be discussed. Case studies using medical device will be utilized to illustrate the statistical requirements.
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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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