Racial minorities have a fraught history of inclusion in unethical clinical trials in the United States, and covid-19 has the potential to further complicate the story. One example of exploitation of minorities in clinical trials was the Tuskegee Syphilis experiments, during which Black men were used as subjects to study the natural course of syphilis, despite readily available penicillin. Meanwhile, contemporary examples of racial injustice in clinical trials include underrepresentation of Black and other minorities. This is where covid-19 is relevant. Despite a disproportionately high covid-19 disease burden amongst the Black, Latinx and Native American populations, these groups are disproportionately underrepresented in ongoing drug trials. This ultimately asks: will such treatments be generalizable and effective across all populations if studies aren't performed in a population representative of the U.S. as a whole?
In a perspective piece published in the New England Journal of Medicine, this continued lack of minority representation in clinical trials is highlighted. In the Adaptive Covid-19 Treatment Trial (ACTT-1), which enrolled 1063 patients, Black, Latinx and Native Americans accounted for only 20 percent, 23 percent, and 0.7 percent of the patients in this study, respectively. Meanwhile, only 11 percent of 397 patients in the Gilead funded Remdesivir study were Black. The crux of the disparity lies in the fact that these studies were conducted in areas where covid-19 related deaths affected these groups at a disproportionately high rate, and their inclusion in these trials was "substantially underrepresented" according to the article. The authors suggest the lack of diversity in these clinical trials is multifactorial and includes an understandable history of mistrust of the medical community from the perspective of minority communities, as well as the financial cost associated with participating in clinical trials. These problems are further compounded by poor health literacy and language barriers. An additional factor is a lack of diversity amongst the principal investigators. It should also be noted that Remdesivir's "compassionate use" program provided no racial or ethnic data for the 53 patients treated, so no conclusions could be drawn from that subset of patients.
Nevertheless, National Institutes of Health (NIH) policy and federal laws mandate the inclusion of racial minorities in NIH funded clinical trials, as well as transparency of racial and ethnic data in phase 3 clinical trials. And yet the Remdesivir studies failed to have adequate representation or even report proper data. While the ACTT-1 did include demographics for patients enrolled, it still failed to provide outcome data linked to gender, race and ethnicity.
When diverse populations are not adequately represented, it is difficult to extrapolate data to the general population. The authors of this article advocate for prioritizing "inclusion of patient populations that reflect the demographics of the ongoing pandemic." Further, they emphasize the importance of increasing funding for scientists belonging to underrepresented ethnic groups and standardizing the reporting of race and ethnicity data. The authors firmly believe that regulatory agencies, medical journals, funders and peer reviewers have the obligation to ensure that clinical trials meet the standards set in place, not only by federal law but also with respect to NIH policy. Future proposals and manuscripts must be able to account for the demographics of their subjects and commit to reporting more nuanced data. NEJM