Simplified Controlled Studies in New Regions for Safety Concern Arising from using Foreign Safety Data

Abstract

To expedite the introduction of new medications and to minimize duplication of clinical trials, many Asian countries have implemented the International Conference on Harmonisation guideline E5, Ethnic Factors in the Acceptability of Foreign Clinical Data, to replace local registration trials before marketing approval of new drugs in their populations. The evaluation, according to the E5 guideline, may determine that direct extrapolation of foreign safety data to the new region is not appropriate. Under such circumstances, bridging studies in the new region are required to generate region-specific safety information to address potential safety concerns. The present article discusses how safety studies in the new regions addressing safety concern arising from using foreign data may be designed, and we use hepatic safety as an example. The discussions focus on desirable types of the studies, the timing for conducting such studies, the appropriate end points and controls, the optimal study duration, and the populations to be studied. By addressing these key design issues, we hope that the results generated by these safety studies can provide adequate race- and population-specific evidence to support the approval of new drugs in the new region.