[Points for Evaluating Japanese Subgroup in the Multi-Regional Clinical Trial]

While the multi-regional clinical trial may accelerate the worldwide development and contribute to avoiding drug lag, differences in the results of efficacy and safety/tolerability among the regions are observed occasionally. These differences complicate the evaluation of clinical value of the study drug. To be able to evaluate consistency of treatment effects across regions, possible intrinsic and extrinsic ethnic factors should be considered at the planning of the study. Although some differences of therapeutic effects across the regions are found, these differences can be attributed to differences in intrinsic or extrinsic factors. Consistency of the efficacy and safety of the anti-cancer drug across the regional subgroups and entire population should be comprehensively examined in the multi-regional clinical trial.