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Activity Number:
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458
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Type:
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Topic Contributed
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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 - #308768 |
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Title:
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Statistics and Clinical, and Regulatory Considerations in the Selection of an Offset for Noninferiority Designs
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Author(s):
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Philip Lavin*+
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Companies:
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Averion International Corp.
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Address:
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225 Turnpike Road, Southborough, MA, 01772,
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Keywords:
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NON-INFERIORITY ; REGULATORY ; OFFSET ; MEDICAL DEVICES ; MCID
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Abstract:
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The choice of an offset (disadvantage to be ruled out) has regulatory, clinical, and statistical motivations and implications. The motivations will be discussed using IDE examples. The implications will be discussed from statistical perspective. There are also hybrid designs where the test device should have a small theoretical advantage, thus dropping sample size. Statisticians also need to be aware of the many computational options for doing binomial calculations since quite wide swings are possible depending on the computational approach used.
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