JSM 2012 Online Program

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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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