JSM 2011 Online Program

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*564 !**	Wed, 8/3/2011, 2:00 PM - 3:50 PM	CC-D234
How Can the Noninferiority Margin Be Defined Where Controlled Trials Historically Lack? — Topic Contributed Papers
Biometrics Section , Biopharmaceutical Section
Organizer(s): Sue-Jane Wang, U.S. Food and Drug Administration/CDER
Chair(s): Tianxi Cai, Harvard University
2:05 PM	Noninferiority Trial Designs and Issues: Community-Acquired Bacterial Pneumonia (CABP) — Daniel Rubin, U.S. Food and Drug Administration ; Thamban Valappil, U.S. Food and Drug Administration
2:25 PM	Noninferiority Assessments in Clinicial Trials: A Nightmare in Practice ? — Hans Ulrich Burger, F. Hoffmann-La Roche Ltd.
2:45 PM	Evaluating Noninferiority Trials for Combination Therapies — Heinz Schmidli, Novartis Pharma AG
3:05 PM	Issues in Determining Noninferiority Limits in Context with Retrospective Comparisons to Placebo — Steven Julious, University of Sheffield
3:25 PM	Methods for Determination of Noninferiority Margin — H.M. James Hung, U.S. Food and Drug Administration
3:45 PM	Floor Discussion

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