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Activity Number:
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73
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Type:
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Contributed
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Date/Time:
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Sunday, August 6, 2006 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305405 |
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Title:
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Critical Statistical Issues in the Design and Analysis of Proof-of-Concept Clinical Trials in Multiple Sclerosis
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Author(s):
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Chris Assaid*+
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Companies:
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Merck & Co., Inc.
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Address:
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P.O. Box 1000, North Wales, PA, 19454-1099,
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Keywords:
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multiple sclerosis ; futility ; inferiority ; imaging endpoints
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Abstract:
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In spite of the proliferation of experimental treatments for MS, an appropriate measure of effect in short-term proof-of-concept (POC) trials as a surrogate for long-term clinical efficacy endpoints remains elusive at best. The typical surrogate in MS POC trials has been based on imaging data and is generally highly variable and skewed. The recent withdrawal of a highly effective treatment also enhances the scrutiny of safety in these trials. Design and analysis approaches for shorter-duration trials that seek to maximize power and the objectivity of the primary endpoint and implement a comprehensive group-sequential approach for monitoring safety and efficacy over the course of the trial that is appropriate for the POC framework will be presented. Discussion will include appropriateness of futility versus inferiority monitoring in this setting.
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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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