Is This the Drug or Dose for You?: Impact and Consideration of Ethnic Factors in Global Drug Development, Regulatory Review, and Clinical Practice

Differences in response to medical products have been observed in racially and ethnically distinct subgroups of the US population.1,2 These differences may be attributable to intrinsic ethnic factors (e.g., genetics, metabolism, and elimination), extrinsic ethnic factors that are associated with environment and culture (e.g., medical practice, diet, use of alcohol, and concomitant drug use), or interactions among these factors (Figure 1).3 Behind these “ethnic” factors, of course, are individual differences that may be more common in particular subgroups but are generally present in all groups, albeit with different frequencies. Although subgroup differences are of great therapeutic and scientific interest, the ultimate goal is to understand these differences so that treatments can be truly individualized. In order to foster a better understanding of how medical products might differ in their performance in individual patients, the US Food and Drug Administration (FDA) requires tabulation in New Drug Applications (NDAs) of the numbers of participants in clinical trials by age group, gender, and race, as well as any Extrinsic