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Legend: Palais des congrès de Montréal = CC, Le Westin Montréal = W, Intercontinental Montréal = I
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355 * Tue, 8/6/2013, 10:30 AM - 12:20 PM CC-510b
Statistical Issues in Noninferiority Trials — Contributed Papers
Biopharmaceutical Section , Biometrics Section , Korean International Statistical Society
Chair(s): Anna Nevius, Food and Drug Administration/CVM
10:35 AM Covariate Effect on Constancy Assumption in Noninferiority Clinical Trials Siyan Xu, Boston University ; Kerry Barker, Pfizer Inc. ; Sandeep Menon, Pfizer Inc. ; Ralph D'Agostino, Sr., Boston University
10:50 AM Misspecification of Event Rates and Sample Size Re-Evaluations in Noninferiority Trials Hwasoon Kim, University of Alabama, Birmingham ; Jeff M Szychowski, University of Alabama at Birmingham
11:05 AM Choosing a Noninferiority Margin for NI Trials in Infectious Disease Therapeutic Area Jing Zhao, BMS ; Seth Thompson, Merck
11:20 AM Determine the Primary Endpoint in Infection Disease Studies Chunzhang Wu, Astellas Pharma Global Development, Inc.
11:35 AM Two Approaches to Noninferiority Margin Derivation Kaihong Jiang, Sanofi ; Xuezhou Mao, Columbia Univ. ; William Stager, Consultant ; Hui Quan, Sanofi ; Marilyn Maroni, Sanofi
11:50 AM A Comparison of Group Sequential Strategies for Three-Arm Noninferiority Trials Toshimitsu Ochiai, Shionogi & Co., Ltd. ; Toshifumi Sugitani, Osaka University Graduate School of Medicine ; Yuko Ohno, Osaka University Graduate School of Medicine ; Toshimitsu Hamasaki, Osaka University Graduate School of Medicine
12:05 PM A Ranking Procedure of Significance Among Combined Noninferiority Studies Using Liapounov's Central Limit Theorem (LCLT) Jagannath Ghosh, PROUnlimited at Novartis ; Mohamed Mubasher, Research and Scientific Publications Center



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