Abstract Details
Activity Number:
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113
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 4, 2014 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #313234
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View Presentation
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Title:
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Go/No Go Criteria Based on a Joint Evaluation of Efficacy and Safety Using a Clinical Utility Index
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Author(s):
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Theresa Ashton*+ and Ohad Amit and Kert Viele
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Companies:
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GlaxoSmithKline and GlaxoSmithKline and Berry Consultants
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Keywords:
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adaptive design ;
utility function ;
go/no go ;
Bayesian methods
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Abstract:
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Traditional go/no go criteria in phase 2 have been based on the evaluation of a drug's efficacy. As there are many different domains involved in the evaluation of patient safety, specifying quantitative go/no go criteria based on safety/tolerability endpoints has been challenging. We propose a set of go/no go criteria based on the joint evaluation of a safety and efficacy endpoint. The evaluation is based on a clinical utility function which assigns different utilities based on different efficacy and safety outcomes. A clinically significant utility is pre-specified and therapies are evaluated against that utility using Bayesian methods. An example of a recently designed adaptive trial is provided to demonstrate the incorporation of go/no go criteria based on the clinical utility index.
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Authors who are presenting talks have a * after their name.
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