title: Exact significance testing to establish treatment equivalence with ordered categorical data.
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.
mesh_terms: D001699:Biometry; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D013810:Therapeutic Equivalency