Svensson C K
Department of Pharmaceutical Sciences, College of Pharmacy, Wayne State University, Detroit, MI 48202.
JAMA. 1989 Jan 13;261(2):263-5.
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.
已揭示药物反应和处置方面存在种族差异的研究表明，在临床药物试验中需要有足够数量的少数族裔代表。然而，有人担心，由于大多数大学医院位于市中心，临床研究中可能会过度使用少数族裔。为了研究这个问题，我们回顾了最近发表的50项新药临床试验中美国黑人的代表性情况。这项调查显示，研究人员似乎没有充分考虑种族差异作为潜在变异性来源的因素。还发现，在大多数研究中，黑人受试者的比例低于他们在总人口中的比例。临床试验中的这种代表性不足表明，缺乏足够的数据来准确评估许多新药在美国黑人中的安全性和有效性。
