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Activity Number: 95
Type: Topic Contributed
Date/Time: Monday, August 7, 2006 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #305356
Title: Noninferiority Testing with a Variable Margin
Author(s): Zhiwei Zhang*+
Companies: U.S. Food and Drug Administration
Address: 1350 Piccard Drive, Rockville, MD, 20850,
Keywords: delta method ; non-inferiority ; likelihood ratio test ; power ; sample size ; score test
Abstract:

There has been growing interest, when comparing an experimental treatment with an active control with respect to a binary outcome, in allowing the noninferiority margin to depend on the unknown success rate in the control group. It does not seem universally recognized, however, that the statistical test should appropriately adjust for the uncertainty surrounding the noninferiority margin. We inspect a naive procedure that treats an "observed margin" as if it were fixed a priori, and explain why it might not be valid. We then derive a class of tests based on the delta method, including the Wald test and the score test, for a smooth margin. We discuss the asymptotic behavior of these tests and the likelihood ratio test when applied to a piecewise smooth margin. Simulation experiments are conducted to evaluate the finite-sample performance of the asymptotic tests studied.

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