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Activity Number:
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430
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Type:
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Contributed
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Date/Time:
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Wednesday, August 5, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304512 |
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Title:
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Estimation vs. Hypothesis Testing in a Decision Analytic Framework
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Author(s):
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Duane Snavely*+ and Kenneth Liu and Richard Entsuah
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc.
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Address:
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, , ,
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Keywords:
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proof of concept ; decision analysis ; futility
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Abstract:
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The primary goal of early clinical trials is to gain information regarding the efficacy and safety of an experimental compound in the target population. This process involves occasions where critical decision making is required, including whether or not drug development should continue based upon pre-specified, quantitative criteria. In a proof of concept trial, knowledge of these criteria during protocol development allows the team to design a trial with optimal operating characteristics in terms of the decisions desired. Stopping early for futility or accelerating development for a superior outcome is also important. We consider two approaches that may be used in this setting: hypothesis testing using group sequential methods, and a confidence interval approach to decision making. An example will be provided to compare the approaches and summarize their advantages/disadvantages.
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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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