Freitag G, Lange S, Munk A
Institut für Mathematische Stochastik, Georg-August-Universität Göttingen, Germany.
Stat Med. 2006 Apr 15;25(7):1201-17. doi: 10.1002/sim.2444.
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.
当数据被删失时，我们建议使用非参数检验来证明新疗法相对于标准疗法的非劣效性。为此，需考虑在特定时间段内整个生存函数的差异和优势比曲线。研究了两种基于自助法近似的渐近方法来解决这些检验问题。在模拟研究中考察了检验程序的性能，并得出了在特定情况下使用哪种检验的一些指导意见。所提出的方法应用于一项比较两种治疗急性心肌梗死溶栓药物的试验，以及一项关于晚期非小细胞肺癌放射治疗的研究。在这两种情况下都可以证明在研究的很长一段时间内具有非劣效性。
