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Abstract Details
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Activity Number:
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37
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Type:
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Contributed
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Date/Time:
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Sunday, July 31, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #300935 |
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Title:
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Estimating Putative Placebo in the Two-Arm Noninferiority Clinical Trial
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Author(s):
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Abdul J. Sankoh*+ and Cynthia DeSouza
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Companies:
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Vertex Pharmaceuticals and Vertex Pharmaceuticals
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Address:
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Vertex Pharmaceuticals, Cambridge, MA, 02139, USA
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Keywords:
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Non-inferiority ;
Putative placebo ;
Superiority ;
Synthesis method ;
Two-arm active-control trial
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Abstract:
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In a two-arm active-control clinical trial, superiority of the test drug to the positive-control does not guarantee that either the test or active-control drug is superior to placebo. Thus in the traditional two-arm active-control non-inferiority trial, one must also show that the test drug is superior to putative placebo in order to minimize the chances of approving new drugs that are no better than placebo. This presentation discusses the design features of an innovative two-arm active-control non-inferiority trial, and presents Monte-Carlo simulation results on the performance of the synthesis method for the estimation of putative placebo in the active-control trial in the presence of trial-to-trial variability.
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Authors who are presenting talks have a * after their name.
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