As the race to develop a vaccine for COVID-19 has reached phase 3 clinical trials, concerns are increasing about the low rates of trial participation in important subgroups, including Black communities. Recent data show that although Black people make up 13% of the US population, they account for 21% of deaths from COVID-19 but only 3% of enrollees in vaccine trials. This problem threatens both the validity and the generalisability of the trial results and is of particular concern in vaccine trials, in which differences in lifetime environmental exposures can result in differences in immunologic responses that could affect both safety and efficacy.
Despite long-standing calls from the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) to improve the participation of underrepresented subgroups in drug trials, the problem persists.
Warren et al., in an article in the New England Journal of Medicine, explore what the barriers are to greater participation of Black people in COVID-19 trials.