Representation of American blacks in clinical trials of new drugs

Abstract

Investigations that have revealed racial differences in drug response and disposition indicate the need for adequate representation of racial minorities in clinical drug trials. There is concern, however, that there may be a disproportionate use of racial and ethnic minorities in clinical research due to the inner city location of most university hospitals. To examine this issue, we reviewed the representation of American blacks in 50 recently published clinical trials of new drugs. This survey revealed that investigators do not seem to adequately take into account racial differences as a potential source of variability. It also was found that in the majority of studies, the proportion of black subjects is less than their proportion in the general population. This underrepresentation in clinical trials suggests that insufficient data exist to accurately assess the safety and efficacy of many new drugs in American blacks.

KIE: The representation of American blacks in 50 recently published clinical trials of new drugs was reviewed for indications of a disproportionate use of racial and ethnic minorities in clinical research related to the inner city location of most university hospitals. The survey reveals that most investigators do not seem adequately to take into account racial differences as a potential source of variability in drug response and disposition. In the majority of studies, the proportion of black subjects is less than their proportion in the general population, suggesting that insufficient data exist to accurately assess the safety and efficacy of many new drugs in American blacks.