This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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408
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Type:
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Contributed
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Date/Time:
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Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #308722 |
Title:
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Optimal Phase II Decision Rules in a Seamless PhaseII/III Clinical Trial
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Author(s):
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Bo Jin*+
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Companies:
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Merck Research Laboratories
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Address:
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, , PA, 18977, USA
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Keywords:
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seameless phase II/III trial ;
utility function ;
non-inferiority
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Abstract:
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In this presentation, we consider a seamless trial where one of a number of experimental treatments is selected in the phase II stage then tested in the phase III stage. Particularly we are interested in the optimal decision rules under the case where a number of criteria are considered in the phase II stage. A utility function is proposed to incorporate these criteria and the optimal decision rule is to select the smallest utility score. A case study is presented for a seamless phase II/III fixed dose combination non-inferiority trial where the phase II is to select the best formulation.
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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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