Racial/ethnic representation in opioid use disorder-related clinical trials

Abstract

BackgroundLittle is known about representation in trials aimed at addressing Opioid Use Disorder. This is a crucial issue given high mortality rates overall and substantial differences in death rates across racial/ethnic groups. MethodsWe analyzed data from clinical trials, data on Census population, data on new admissions to treatment facilities with a diagnosis of Opioid Use Disorder, and mortality data. ResultsWe found that Native American people (who face the highest opioid-related mortality burden in the United States) were under-represented in clinical trials. Black people (who face the second highest mortality rate) were enrolled at levels that exceeded those expected. Our results suggest the need for increased efforts to include Native Americans in OUD clinical trials and also that researchers should consider the possibility that high levels of enrollment among black Americans may represent an undue burden. We found ambiguous results for Asian American and Hispanic people. Our analysis also suggests that White people were represented at levels below those expected, although they were a majority of clinical trials participants. ConclusionOverall, these findings highlight the importance of equity in clinical trials and major gaps in terms of representation.