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Abstract Details
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Activity Number:
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452
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 1, 2012 : 8:30 AM to 10:50 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306222 |
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Title:
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The ABC Assumptions of Setting a Noninferiority Margin: When the Margin Assumptions Can Be Violated
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Author(s):
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Steven Julious*+
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Companies:
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University of Sheffield
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Address:
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Regent Court, , SHEFFIELD , S1 4DA, UK
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Keywords:
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Clinical trials ;
Indirect comparisons ;
Non-inferiority ;
Placebo creep
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Abstract:
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In a non-inferiority trial to assess a new investigative treatment there may need to be consideration of an indirect comparison with placebo using the active control in the current trial. We can therefore use the fact that there is a common active control to make comparisons of the investigative treatment and placebo. In analysing a non-inferiority trial, the ABC of: Assay sensitivity; Bias minimisation and Constancy assumption; needs to be considered. It is highlighted how the ABC assumptions can potentially fail when there is placebo creep or a patient population shift. The implications of the results will be highlighted
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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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