title: Non-parametric assessment of non-inferiority with censored data.
abstract: We suggest non-parametric tests for showing non-inferiority of a new treatment compared to a standard therapy when data are censored. To this end the difference and the odds ratio curves of the entire survivor functions over a certain time period are considered. Two asymptotic approaches for solving these testing problems are investigated, which are based on bootstrap approximations. The performance of the test procedures is investigated in a simulation study, and some guidance on which test to use in specific situations is derived. The proposed methods are applied to a trial in which two thrombolytic agents for the treatment on acute myocardial infarction were compared, and to a study on irradiation therapies for advanced non-small-cell lung cancer. Non-inferiority over a large time period of the study can be shown in both cases.
authors.affiliation: Institut für Mathematische Stochastik, Georg-August-Universität Göttingen, Germany. freitag@math.uni-goettingen.de
authors.forename: G
authors.initials: G
authors.lastname: Freitag
authors.forename: S
authors.initials: S
authors.lastname: Lange
authors.forename: A
authors.initials: A
authors.lastname: Munk
mesh_terms: D003198:Computer Simulation; D016001:Confidence Intervals; D018849:Controlled Clinical Trials as Topic / Q000379:methods*; D003627:Data Interpretation, Statistical; D006801:Humans; D015233:Models, Statistical; D016017:Odds Ratio; D016016:Proportional Hazards Models; D012107:Research Design; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D013810:Therapeutic Equivalency; D016896:Treatment Outcome