JSM 2011 Online Program

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Activity Details


116 * Mon, 8/1/2011, 8:30 AM - 10:20 AM CC-C225/226
Noninferiority Trial Design Issues for Medical Devices — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Heng Li, U.S. Food and Drug Administration/CDRH, Hsini Terry Liao, Boston Scientific Corporation
Chair(s): Vandana Mukhi, U.S. Food and Drug Administration/CDRH
8:35 AM Practical Issues in Noninferiority Trials Chul H. Ahn, U.S. Food and Drug Administration/CDRH
8:55 AM Noninferiority Tests for Binomial Endpoints in Two-Arm Medical Device Trials Maria Carola Alfaro, Boston Scientific Corporation ; Edmund McMullen, Boston Scientific Corporation
9:15 AM Noninferiority Testing with a Variable Margin Yonghong Gao, U.S. Food and Drug Administration/CDRH
9:35 AM Binomial Confidence Intervals for Testing Noninferiority or Superiority: A Practitioner's Dilemma Vivek Pradhan, Boston Scientific Corporation ; John C Evans, Boston Scientific Corporation ; Tathagata Banerjee, IIMA
9:55 AM Elicitation of Noninferiority Margin Xiting "Cindy" Yang, U.S. Food and Drug Administration/CDRH
10:15 AM Floor Discussion



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