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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 - #303591 |
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Title:
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Monitoring Adaptive Clinical Trials
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Author(s):
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Zoran Antonijevic*+
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Companies:
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Quintiles, Inc.
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Address:
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8 Teahouse Ct., Durham, NC, 27707,
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Keywords:
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adative design ;
monitoring ;
case studies
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Abstract:
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The FDA Draft Guidance for Adaptive Design Clinical Trials identifies the operational bias as one of the greatest concerns associated with implementation of Adaptive Clinical Trials. The primary cause of the operational bias is the information leakage during the unblinded interim analysis. The focus of this presentation will be on the adaptive clinical trials interim decision process and the information flow during interim analyses. Case studies will be presented, with emphasis on the "problematic" ones. For each case study the design will first be described, which will then be followed by description of the data monitoring model.
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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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