Defining Regions in Multiregional Clinical Trials: An Analytical Approach to Considering Impact of Intrinsic and Extrinsic Factors

摘要

Background: This article describes follow-up work extended from Tanaka et al (2011) in defining the region in multiregional clinical trials (MRCTs). The previous paper advocated a systematic approach to defining regions and recommended the sponsor to think through carefully, prespecify, and justify any regional definitions as well as obtain regulatory concurrence prior to study conduct. Particular attention was advised for intrinsic and extrinsic factors such as race/ethnicity, disease epidemiology, medical practice, and geographic proximity. An analytical approach such as a cluster method to define region was introduced, and references on observed regional differences were provided.