JSM 2012 Online Program
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Online Program HomeActivity Details
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452 * ! | Wed, 8/1/2012, 8:30 AM - 10:50 AM | CC-Room 25C | |
Issues in Noninferiority Assessment Trials When Active-Control Changes Over Time Due to Improved Efficacy — Topic Contributed Papers | |||
Biopharmaceutical Section | |||
Organizer(s): Abdul J Sankoh, Vertex Pharmaceuticals | |||
Chair(s): Abdul J Sankoh, Vertex Pharmaceuticals | |||
8:35 AM | An Overview of Active-Controlled Clinical Trials and Some New Issues — Greg (Guoxing) Soon, FDA | ||
8:55 AM | Non-Constancy Adjustment for Non-Inferiority Testing in Active-Controlled Clinical Trials — Carl Dicasoli, Vertex Pharmaceuticals ; Emily Martin, Vertex Pharmaceuticals ; Cynthia Desouza, Vertex Pharmaceuticals | ||
9:15 AM | The ABC Assumptions of Setting a Noninferiority Margin: When the Margin Assumptions Can Be Violated — Steven Julious, University of Sheffield | ||
9:35 AM | Active Control Trials with Adaptive Modification of Margin to Address Nonconstancy — Scott Emerson, University of Washington ; Siobhan P. Brown, University of Washington | ||
9:55 AM | Discussant: Susan S Ellenberg, University of Pennsylvania | ||
10:15 AM | Floor Discussion |
2012 JSM Online Program Home
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