This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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289
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 3, 2010 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307227 |
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Title:
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A Case Study of Issues with Subgroup Analysis for Medical Devices
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Author(s):
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Yao Huang*+ and Yunling Xu
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Companies:
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FDA/CDRH and FDA/CDRH
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Address:
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10903 New Hampshire Avenue, Silver Spring, MD, 20993,
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Keywords:
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subgroup analysis ;
medical device ;
clinical trials
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Abstract:
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When submitting a pre-market application, sponsors are interested in making full use of the data collected from clinical studies. One of the approaches is to perform various subgroup analyses hoping to identify additional beneficial evidence to the devices. From the regulatory perspective, it is recommended that subgroup analysis be prespecified in study protocols to take account of the issue of multiplicity. This case study will examine where subgroup analyses being prespecified, how trustable the results of such analyses truly are.
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Authors who are presenting talks have a * after their name.
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