Tu D
Clinical Trials Group, National Cancer Institute of Canada, Queen's University, Kingston, Ontario, Canada.
J Biopharm Stat. 1998 May;8(2):263-82. doi: 10.1080/10543409808835238.
We discuss in this paper some issues related to the use of the ratio or the odds ratio of cure rates in therapeutic equivalence clinical trials with binary endpoints. Some two one-sided tests procedures are proposed and their fixed sample performances evaluated by Monte Carlo simulations. Sample size formulas are derived for most of these procedures. The consequences of applying acceptance limits proposed for pharmacokinetic responses in bioequivalence studies to clinical endpoints in therapeutic equivalence clinical trials are also described.
我们在本文中讨论了与具有二元终点的治疗等效性临床试验中治愈率的比率或比值比的使用相关的一些问题。提出了一些双单侧检验程序，并通过蒙特卡罗模拟评估了它们的固定样本性能。为这些程序中的大多数推导了样本量公式。还描述了将生物等效性研究中针对药代动力学反应提出的接受限度应用于治疗等效性临床试验中的临床终点的后果。
