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Abstract Details
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Activity Number:
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99
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Type:
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Invited
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Date/Time:
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Monday, July 30, 2012 : 8:30 AM to 10:20 AM
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Sponsor:
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Pharmaceutical Research and Manufacturers of America
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| Abstract - #303613 |
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Title:
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Emerging Experiences on Adaptive Clinical Trial Data Monitoring
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Author(s):
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Sue-Jane Wang*+
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Companies:
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FDA
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Address:
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10903 New Hampshire Ave, Silver Spring, MD, , USA
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Keywords:
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Trial Logistics Model ;
Confirmatory ;
Adaptive Trial ;
firewalls ;
Adaptive Data Monitoring
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Abstract:
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It is well recognized that adaptive design allows multiple ways to win due to the choices among the multiple hypotheses initially set out with. Both statistical validity and trial integrity are key components of a successful confirmatory adaptive trial. This presentation will focus on approaches to trial logistics for maintaining trial integrity in confirmatory adaptive trial. I will present regulatory experiences of adaptive trial logistics models. These models will be illustrated via some typical case examples.
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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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