JSM 2011 Online Program
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Activity Details
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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 |
2011 JSM Online Program Home
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