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Abstract Details
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Activity Number:
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131
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Type:
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Contributed
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Date/Time:
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Monday, August 1, 2011 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302363 |
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Title:
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Justification of Noninferiority Design in Infection Disease Studies
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Author(s):
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Chunzhang Wu*+
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Companies:
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Astellas Pharma Global Development, Inc.
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Address:
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3 Parkway North, Deerfield, IL, 60015,
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Keywords:
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non-inferiority margin ;
sensitivity ;
placebo effects ;
random effects
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Abstract:
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In infection disease area, non-inferiority (NI) design is a most acceptable methodology to design the clinical trials to support regulatory submission in recent decades. However the justification of the design, in particular the sensitivity and the selection of non-inferiority margin, is a critical challenge for a successful clinical trial. Using some successful historical and existing clinical trials related to antifungal disease, this paper illustrates statistical/clinical justification of NI design in accordance with major regulatory guidance. The sensitivity and the selection of non-inferiority margin is a primary focus. It is also in depth discussed that how to obtain conservative and reliable estimate of placebo effect when placebo control trials were not feasible in infection disease area in most health care practice.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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