title: Test Statistics and Confidence Intervals to Establish Noninferiority between Treatments with Ordinal Categorical Data.
abstract: The problem for establishing noninferiority is discussed between a new treatment and a standard (control) treatment with ordinal categorical data. A measure of treatment effect is used and a method of specifying noninferiority margin for the measure is provided. Two Z-type test statistics are proposed where the estimation of variance is constructed under the shifted null hypothesis using U-statistics. Furthermore, the confidence interval and the sample size formula are given based on the proposed test statistics. The proposed procedure is applied to a dataset from a clinical trial. A simulation study is conducted to compare the performance of the proposed test statistics with that of the existing ones, and the results show that the proposed test statistics are better in terms of the deviation from nominal level and the power.
authors.affiliation: a Biomedical Data Sciences Department , GlaxoSmithKline K.K. , Tokyo , Japan.
authors.forename: Fanghong
authors.initials: F
authors.lastname: Zhang
authors.forename: Etsuo
authors.initials: E
authors.lastname: Miyaoka
authors.forename: Fuping
authors.initials: F
authors.lastname: Huang
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Tanaka
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003198:Computer Simulation; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D023381:Endpoint Determination; D006801:Humans; D016013:Likelihood Functions; D015233:Models, Statistical; D009716:Numerical Analysis, Computer-Assisted; D012107:Research Design / Q000706:statistics & numerical data*; D018401:Sample Size; D016896:Treatment Outcome
keywords: Noninferiority margin; Shifted null hypothesis; U-statistics; Wilcoxon–Mann–Whitney test; Z-type test.