Diversity in COVID-19 Trials

Man using micropipette to perform COVID-19 test
State Public Health Laboratory in Exton Tests for COVID-19. Source: Governor Tom Wolf, Creative Commons.

Since COVID-19 became a pandemic, researchers have been rushing to develop an effective vaccine. There has been a lot of progress made in a short amount of time, but one barrier that every trial in the United States is facing is a lack of diversity within the trials. This is not uncommon for modern research trials, as the majority of participants are typically white and males. However, for a trial to demonstrate effectiveness and appropriate dose for the population, the study population needs to be representative of the whole population at risk.

When studies don’t have a diverse study population, there are adverse outcomes and side effects that are not accounted for. For example, about one in five medications has a different recommended dose across different racial and ethnic populations. This means that without diverse trials, doctors won’t know how safe the medicines that they prescribe their patients actually are.

For the COVID-19 vaccine trials, the issue of diversity is particularly important because people of color, specifically the Latinx and Black communities, are not only three times more likely to contract COVID-19 than white Americans, but they’re also twice as likely to die. Despite this health inequity, people of color only make up 29% of participants in the vaccine trial with the most diversity. This is an improvement from most studies, but still not representative of the affected population: 49.9% of the United States population is not white, and people of color experience severe cases of COVID-19 at a higher rate.

But why is it so hard to achieve representative diversity in trials? The main reason is that the United States has a history of taking advantage of people of color when performing medical studies. One of the most glaring examples of this is the “Tuskegee Study of Untreated Syphilis in the Negro Male” in which almost 400 Black men were diagnosed with syphilis and left untreated. They were promised free food and physicals but were never informed of their diagnosis. Despite the discovery of penicillin, which is an effective treatment for syphilis, while the trial was still ongoing, none of the men involved in the study were ever treated. Because of this, many of them died, and many of their wives and children also contracted syphilis. The study ended after 40 years when a public health service investigator informed the press of what was going on.

The Tuskegee Study was devastating for the men who unknowingly participated and their families, but the effects did not stop with them. Because of the dishonesty within this study, Black American patients are less likely to trust their doctors and the medical system as a whole. A study done by Marcella Alsan and Marianne Wanamaker showed that immediately following the news of the Tuskegee Study, health outcomes, trust of medical professionals, and life expectancy all decreased, which shows not only a social effect but a physical one.

Mural of Henrietta Lacks with description "Henrietta Lacks, a poor black farmer, died in 1951 of cervical cancer. Her tumor cells were taken without her knowledge, and became the first human culture cells because they were found to divide indefinitely. Her cells have saved countless lives. Jannai B"
Henrietta Lacks. Source: yooperann, Creative Commons.

Another case that plants seeds of distrust towards the medical community is the case of Henrietta Lacks. Lacks was an Black American woman being treated for cervical cancer at Johns Hopkins in the early 1950s. During treatment, and without her knowledge, doctors took samples of her cervical cells to see if they would replicate in culture, which they did. HeLa cells, as they are now called, were a huge breakthrough for medical research, but it was done without Lacks’ knowledge and consent. Additionally, her family received no compensation and has only recently gotten a say and acknowledgement in research that uses HeLa cells. Because of these two injustices, many Black Americans have little trust in the medical systems.

Black Americans are less likely to seek medical treatment and participate in trials, which leads to worse health outcomes immediately and for future generations. Because they are less likely to seek medical treatment, conditions will worsen before seeing a doctor, and treatment in later stages is more costly—financially and personally. Additionally, because of the lack of participation in trials, as discussed earlier, we don’t know about the presentation of diseases and the side effects that people of color experience. The small percentage of Black Americans that do participate in trials are often reminded by their friends and family of the injustices of the past, urging them not to participate.

How do we fix this problem? This issue is deeper than implementing policies to require more diversity, protect research participants, and ensure they have the full knowledge of the trial before going into it; all of that has already been done, and these policies have done little to increase diversity in trials. What is really needed now is to build back trust. To do this completely will take decades, but for now there are some short term plans.

To increase diversity in COVID-19 vaccine trials, pharmaceutical companies are enlisting historically Black medical schools, such as Meharry Medical College and Morehouse School of Medicine, to carry out trials. Studies have found that patients that have similar racial and ethnic backgrounds to their physicians trust their doctors more. By using this information, these predominantly black medical schools, which predominantly serve Black patients, are able to reassure their patients that the study that they are enrolling in will not repeat history.

While the effort of diversifying trials is important for COVID-19 trials, it must not end there. Many people are trying to publicize the safeguards that all studies have today, which prevent any injustices like what happened in the Tuskegee Study and in the collection of cells from Henrietta Lacks. However, this information must come from people that the patients trust. The medical community must work to rebuild trust in communities of color so that we can decrease the health inequities experienced and understand the safety of medications and vaccines for the whole population instead of just for white males.