Who is being left out of COVID-19 research?
As scientists test treatments and vaccines against COVID-19, we asked Infectious Disease News Editorial Board Member Peter Chin-Hong, MD, professor of medicine and director of the transplant infectious disease program at the University of California, San Francisco, which populations are being left out of COVID-19 research and what needs to happen to make the process more inclusive.
One of the most important features to assess whether a research study passes muster is generalizability. The first thing I usually do is turn to Table 1 — often the part of the paper that lists demographic and other baseline characteristics — and ask, “Would this patient in front of me in clinic or in the hospital have been eligible for this study?” Sadly, the answer from clinical trial data is often “no.”
Many of the patients I take care of — immunocompromised patients and the elderly — as well as other populations such as children, are often excluded in clinical trials. But perhaps the most heartbreaking deficiency is the lack of inclusion of diverse populations.
In a study looking at pivotal cardiovascular drug clinical trial participation by race and ethnicity over 10 years, 2% were black and 2% were Latinx (Blacks comprise 13% of the U.S. population and Latinx, 18%).
The situation with COVID-19 research is no rosier. Despite having an outsized burden of COVID-19-associated diagnoses, hospitalizations and deaths, the representation of minority populations pales in comparison to their disease incidence. Blacks have five times the COVID-19 hospitalization rates and more than twice the deaths compared with white patients. However, in the Gilead-sponsored SIMPLE trial looking at 5 vs. 10 days of remdesivir treatment, only 11% of the participants were Black, and Latinx ethnicity was not reported.
When looking at published COVID-19 vaccine trials to date, participation disparities are starker: The early phase AstraZeneca/Oxford and Moderna vaccine reports included 1% and 4% Black study subjects, respectively. There are myriad explanations for this. Most COVID-19 studies are based at large academic institutions that may have differential commitment to minority populations. Other factors include the hidden costs of trial participation, such as parking; needing time off from work/child care if an outpatient; language and health literacy; and implicit bias on the part of investigators. One of the most important barriers is the lack of trust that many in the Black community and other minorities have toward the medical establishment and science, stemming from the Tuskegee syphilis study and other unethical work that exploited these populations.
In an Axios-Ipsos poll conducted in August, less than 30% of Blacks were willing to take a COVID-19 vaccine if it were currently available. There are steps that can and are being taken to address this problem: specific outreach and marketing, partnership with community organizations and churches, taking advantage of the partnerships formed by doing decades of HIV research in diverse populations — but there is much more to be done.
The NIH and other funders should agree on benchmarks for success that optimize a diverse pool of research participants, and journal editors could insist on full transparency regarding recruitment strategies in submitted work. Ultimately this is a marathon, not a sprint. We need to continue to diversify not only the research coordinators, but the doctors, nurses, faculty and principal investigators so they persist and represent, and ask the right questions from the communities from which they arise.
- Axios-Ipsos poll: The racial gap on coronavirus vaccine. https://www.axios.com/axios-ipsos-poll-coronavirus-index-vaccine-racial-trust-gap-28629c26-ef99-416c-ad60-03a43d725e67.html. Accessed September 30, 2020.
- Goldman JD, et al. N Engl J Med. 2020;doi:10.1056/NEJMoa2015301.
- Kahn MS, et al. J Am Heart Assoc. 2020;doi:10.1161/JAHA.119.015594.
Click here to read the Cover Story, "Leaving women out of study populations can cause ‘great harm’.”