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Exact Significance Testing to Establish Treatment Equivalence with Ordered Categorical Data

Cyrus R. Mehta, Nitin R. Patel and Anastasios A. Tsiatis
Biometrics
Vol. 40, No. 3 (Sep., 1984), pp. 819-825
DOI: 10.2307/2530927
Stable URL: http://www.jstor.org/stable/2530927
Page Count: 7
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Exact Significance Testing to Establish Treatment Equivalence with Ordered Categorical Data
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Abstract

This communication concerns the problem of establishing the therapeutic equivalence of two treatments that are being compared on the basis of ordered categorical data. The problem is formulated as a significance test in which the null hypothesis specifies a treatment difference. An efficient numerical algorithm for computing the exact significance level is provided, along with a simple method for obtaining the asymptotic significance level. Both methods are applied to a clinical trial of a new agent versus an active control. Guidelines for when to use the exact procedure and when to rely on asymptotic theory are provided.

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