Inclusion of Under-Represented Racial and Ethnic Groups in Cardiovascular Clinical Trials.

Abstract

Non-White racial and ethnic groups have been traditionally under-represented for decades in the field of cardiology, specifically in cardiovascular research studies. This underrepresentation has occurred despite the fact that these racial and ethnic groups have been shown to be at increased risk of cardiovascular disease (CVD). To assess the trend of representation in mainstream landmark cardiovascular trials, we performed a review of major cardiovascular trials published between 1986 and 2019. Mainstream landmark trials were selected as classified by established cardiology standards. The reported numbers of racial and ethnic participants were assessed within these categorised cardiovascular trials over a continuous time period. A total of 1,138,683 patients were assessed from 153 randomised clinical trials. Of these trials, only 56% (n=86) reported information about race. Of note, 99% (n=152) of these trials reported gender. About three-quarters of the trials (77%) were undertaken at least partly in the United States (US). Our results show that the percentage of non-White participants in clinical trials was not significantly different over time (p=0.85), suggesting no significant improvement in non-White racial/ethnic representation. Further analysis of only the US inclusive trials (n=20) also showed no significant improvement in representation (p=0.38). Only about half of all major cardiovascular landmark trials reported any racial or ethnic information, despite more recent calls over the last 5-10 years for diversity and representation in cardiovascular research studies. Additionally, no significant improvement in inclusion of traditionally under-represented racial and ethnic groups (UREGs) in these trials has occurred over time. Our analysis shows that there is still major work to be done to foster better representation and evaluation of the UREG population in cardiovascular trials.