JSM 2011 Online Program

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Activity Details

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

2011 JSM Online Program Home

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