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Activity Number:
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246
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Type:
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Contributed
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Date/Time:
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Tuesday, July 31, 2007 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308334 |
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Title:
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Optimal Cost-Effective Designs of Proof of Concept Trials
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Author(s):
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Cong Chen*+
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Companies:
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Merck & Co., Inc.
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Address:
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1019 Brassington Dr, Collegeville, PA, 19426,
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Keywords:
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efficiency score ; oncology ; optimal design
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Abstract:
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This presentation discusses optimal cost-effective designs for proof of concept (PoC) trials. Unlike a confirmatory registration trial, a PoC trial is exploratory in nature and sponsors of such trials have the liberty to choose type I error rate and the power. The decision is largely driven by the perceived probability of having a truly active treatment per patient exposure (a surrogate measure to development cost), which is naturally captured in an efficiency score to be presented. Optimization of the score function leads to type I error rate and power (and therefore sample size) for the trial that is most cost-effective. The idea is applied to derive optimal trial-level, program-level and franchise-level design strategies. From the examples provided herein, the audience should be able to gain much-needed insight in similar design problems and participate in strategic decisions.
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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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