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Activity Details

500 * Wed, 8/6/2014, 10:30 AM - 12:20 PM CC-258B
Noninferiority and Equivalence Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): Lisa Rodriguez, FDA   
10:35 AM Sample Size Determination for a Three-Arm Equivalence Trial of Poisson Distributed Responses Victoria Chang ; Yi Tsong, FDA ; Zhigen Zhao, Temple University
10:50 AM The Application of Improved Fallback Procedure to Testing Noninferiority and Superiority for Multiple Endpoints Huiling Li, Forest Research Institute ; Yong Wang, Forest Research Institute ; Kaifeng Lu, Forest Research Institute
11:05 AM Get More Information from Recurrent Events Data Wayne Nelson, Wayne Nelson Statistical Consulting
11:20 AM Bayesian-Augmented Control Methods for Efficiently Incorporating Historical Information in Clinical Trials Carl Dicasoli, Bayer Healthcare Pharmaceuticals ; Michael Kunz, Bayer Healthcare Pharmaceuticals ; Daniel Haverstock, Bayer Healthcare Pharmaceuticals
11:35 AM Assessing Subgroup Consistency in Noninferiority Clinical Trials Oliver Lee, Amgen ; Kathy Zhang, Amgen ; Alan Rong, Amgen
11:50 AM Mid-Course Sample Size Modification in Group-Sequential Designs for Three-Arm Noninferiority Clinical Trials Toshimitsu Ochiai, Shionogi & Co. ; Yuko Ohno, Osaka University Graduate School of Medicine ; Toshimitsu Hamasaki, Osaka University Graduate School of Medicine
12:05 PM A Noninferiority Test for a Matched Pair Design with an Ordinal Outcome with a Majority of Zeros Wanjie Sun, FDA

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