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Abstract Details
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Activity Number:
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564
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biometrics Section
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| Abstract - #300565 |
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Title:
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Noninferiority Assessments in Clinicial Trials: A Nightmare in Practice ?
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Author(s):
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Hans Ulrich Burger*+
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Companies:
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F. Hoffmann-La Roche Ltd.
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Address:
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Zähringerstr. 58, Neuenburg, 79395, Germany
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Keywords:
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Non-inferiority ;
Risk-benefit assessment ;
PFS ;
Overall survival
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Abstract:
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In situations were standard superiority trials for efficacy are not applicable, non-inferiority designs are an alternative to demonstrate efficacy of a new compound as well as to allow an adequate risk benefit assessment. The basic design features of such trials are known since quite some time, the implementation in practise can pose, however, still a number of challenges, in terms of design as well as in the interpretation of the results. This talk will present some examples and by that highlight the difficulties we still have today with such designs, in the definition of a suitable non-inferiority margin, in the interpretation of results and in its potential regulatory implications.
Please note Sue Jane Wang is the session organizer
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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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