Qualitative Consistency of Treatment Effects in Multiregional Clinical Trials

Abstract

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.