ABSTRACT
In clinical research and development, it is well recognized that ethnic factors may have signi‚cant in©uence on clinical outcomes for evaluation of ef‚cacy and safety of study medications under investigation, especially when the sponsor is interested in bringing an approved drug product from the original region (e.g., the United States or the European Union) to a new region (e.g., Asia-Paci‚c region). To determine if clinical data generated from the original region are acceptable in the new region, the International Conference on Harmonisation (ICH) issued a guideline titled “Ethnic Factors in the Acceptability of Foreign Clinical Data” in 1998. The purpose of this guideline is not only to permit adequate evaluation of the in©uence of ethnic factors but also to minimize duplication of clinical studies in the new region.
