The Importance of Ethnicity

Concerns about ethnicity-related differences have resulted in a significant “drug lag” in regulatory approvals. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) document on Ethnic Factors in the Acceptability of Foreign Clinical Data, ICH E5, provides guidelines for assessing ethnicity as a cause of differences in drug treatment, and the use of bridging strategies to avoid unnecessary duplication of clinical trials without compromising the quality, safety and efficacy of the drug, with the goal of expediting the drug approval process. These guidelines have however not been fully adopted by all countries, and there are differences in the way the bridging concept is applied. An approach, which may provide the resolution to this dilemma, is the multi-regional parallel bridging method, or simultaneous drug development. However, the definition of ethnicity is currently too vague and imprecise for clinical trial data to be easily understood and extrapolated across borders. The integration of pharmacogenomics and biomarkers in drug development may provide greater clarity to the characterization of drug response variability between populations.