Tanaka Yoko, Li Gang, Wang Yining, Chen Josh
Eli Lilly and Company, Indianapolis, Indiana 46285, USA.
J Biopharm Stat. 2012 Sep;22(5):988-1000. doi: 10.1080/10543406.2012.703603.
Consistency of treatment effects across different regions in multiregional clinical trials (MRCTs) has been an important question for the regulatory authorities. Many consistency definitions are proposed in literature. One of the definitions of consistency is expressed as qualitative consistency, whereas inconsistency is defined as qualitative treatment by region interaction. This article focuses on the qualitative consistency and extends Gail-Simon and Sasabuchi's one-sided multivariate likelihood ratio tests. Simulations are used to evaluate operating characteristics of these qualitative consistency assessment approaches. For a given number of regions, the guideline for setting significance level, and consistency cut-off are explored.
在多区域临床试验（MRCTs）中，不同区域治疗效果的一致性一直是监管机构关注的重要问题。文献中提出了许多一致性的定义。一致性的定义之一被表述为定性一致性，而定性不一致则被定义为治疗效果因区域而异的相互作用。本文聚焦于定性一致性，并扩展了盖尔 - 西蒙和笹渕的单侧多变量似然比检验。通过模拟来评估这些定性一致性评估方法的操作特性。对于给定数量的区域，探讨了设定显著性水平和一致性临界值的指导原则。
