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Activity Number:
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445
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Type:
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Invited
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Date/Time:
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Wednesday, August 1, 2007 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308038 |
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Title:
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Early Developments in Clinical Equivalence and Similarity Trials
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Author(s):
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William C. Blackwelder*+
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Companies:
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University of Maryland, Baltimore County
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Address:
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c/o 8613 Hempstead Avenue, Bethesda, MD, 20817-6711,
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Keywords:
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Clinical equivalence ; Similarity ; Noninferiority ; Clinical trials
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Abstract:
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Studies designed to show a new treatment is not worse than an active control by as much as a specified quantity are now common. Work in the late 1970s on a study of reduced duration of therapy for serious fungal infection led to the 1982 Controlled Clinical Trials paper. In a 1978 paper Makuch and Simon had addressed the same problem. "Equivalence" and "similarity" have been used to describe this type of trial. "Noninferiority" is now generally used, but it must be understood as shorthand for "not inferior by as much as a specified quantity". Null hypotheses of non-equality have also been used in other settings - for example, in trials designed to show vaccine efficacy is greater than a specified positive value.
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