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Abstract Details
Activity Number:
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485
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Type:
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Invited
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Date/Time:
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Wednesday, August 3, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Statistics in Biopharmaceutical Research Journal
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Abstract - #300344 |
Title:
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Inferiority Index and Margin Specification in One-Sided Equivalence Studies
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Author(s):
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George Y. H. Chi*+ and Gang Li
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Companies:
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Johnson & Johnson Pharmaceutical R&D, LLC and Johnson & Johnson Pharmaceutical R&D, LLC
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Address:
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920 US Highway 202 S, Raritan, NJ, 08869,
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Keywords:
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inferiority index ;
margin ;
degree of tightness ;
non-inferiority trial ;
comparative study
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Abstract:
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In (one-sided) equivalence studies, the setting of an equivalence margin has often been controversial. This is true for example in non-inferiority trials. Much of the problems can be traced to a lack of an objective standard for measuring the stringency of a margin. In this presentation, we will introduce the concept of an inferiority index. It will be shown that under different types of distributions, the inferiority index can be linked to a given effect measure of interest. Through this link, the inferiority index can then provide a measure of the degree of tightness of a given margin for the effect measure. In addition, through this link, a margin can be specified with the desired level of stringency, although in practice, this should be done in conjunction with other relevant information. Its applications to non-inferiority trials will be illustrated with examples from survival, normal and Bernoulli distributions. Potential applications to other comparative studies will be noted.
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