JSM Preliminary Online Program
This is the preliminary program for the 2007 Joint Statistical Meetings in Salt Lake City, Utah.

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Activity Number: 154
Type: Contributed
Date/Time: Monday, July 30, 2007 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #310404
Title: Noninferiority Testing with a Given Percentage of the Control as the Noninferiority Margin
Author(s): Paul Hshieh*+
Companies: Food and Drug Administration
Address: 1401 Rockville Pike, Rockville, MD, 20852,
Keywords: Noninferiority ; noninferiority margin ; mean ratio ; mean difference
Abstract:

In the evaluation of blood products, a given percentage (e.g., 20%) of the control mean is often used as a noninferiority (NI) margin; however, calculation of this margin using the control sample mean is problematic because doing so does not take the variability of the estimate into consideration. Furthermore, NI margin should be fixed in the design stage; it should not be computed or estimated from the current data. To resolve these problems, the noninferiority hypothesis may be formulated based on the mean ratio rather than the mean difference. Such a hypothesis may be tested using different approaches. Real examples will be discussed.

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Revised September, 2007