Abstract Details
Activity Number:
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44
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Type:
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Contributed
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Date/Time:
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Sunday, August 9, 2015 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #317167
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View Presentation
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Title:
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Ruling Out a Safety Margin
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Author(s):
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Kunthel By* and Thomas Ly and John Yap and Jessica Kim
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Companies:
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and FDA and FDA and FDA
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Keywords:
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rule-out ;
rare events ;
non-inferiority ;
safety margin
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Abstract:
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Post-market safety outcome studies to evaluate risk are often conducted as a condition of approval (PMR/PMC) or after a post-market signal has been elicited. Often, these studies are designed to detect a pre-specified relative risk under the alternative hypothesis. We discuss challenges associated with interpretation of results under this type of hypothesis testing in the setting of safety studies. We consider a ruling-out approach as an alternative hypothesis testing paradigm that may address some of these challenges. Difficulties associated with conducting rule-out studies such as sample size and margin selection will also be discussed.
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Authors who are presenting talks have a * after their name.
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