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Abstract Details
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Activity Number:
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160
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 1, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302022 |
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Title:
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Monitoring Adaptive Clinical Trials: Case Studies
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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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Center for Statistics in Drug Development Innovation, Durham, NC, 27707,
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Keywords:
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adaptive design ;
clinical trial ;
interim decision process ;
interim monitoring
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Abstract:
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The emphasis of this presentation will be on the adaptive clinical trials interim decision process. Three case studies will be presented. For each case study the design will first be described, which will then be followed by description of the data monitoring model. First case study has a model in which all information is communicated to the sponsor by the independent statistical center (ISC). In second case study all information goes from the ISC to the DSMB, which then makes a recommendation to the sponsor. In third case study efficacy decision is communicated to the sponsor directly by the ISC, while safety recommendation is presented by the DSMB.
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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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