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August 2019

Exact Significande Testing to Establish Treatment Equivalence with Ordered Categorical Data

Author(s): Patel, N., Tsiatis, A.

Journal/Book: Biometrics. 1984; 40: 819-825.

Abstract: This communication concerns the problem of establishing the therapeutic equivalence of two treatments that are being compared an 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 an asymptotic theory are provided.

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