Although racial minorities experience disproportionality higher rates of COVID-19 infection, hospitalization, and death, they are significantly underrepresented in COVID-19 clinical trials, according to a new perspective article.
The viewpoint appears in the New England Journal of Medicine (NEJM).
In the United States, Black, Hispanic, and other racial minorities are more likely than whites to contract, be hospitalized, or die with COVID-19.
Recent Centers for Disease Control and Prevention (CDC) data reveal that Blacks, Hispanics, and American Indians are nearly three times as likely as whites to contract the virus and almost five times as likely to be hospitalized with COVID-19.
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Furthermore, all three groups are more likely to die from COVID-19 than white people, with Black people twice as likely to die. Asian American people are also more likely to contract the virus and be hospitalized than white people. Consequently, minority groups will likely use COVID-19 drugs expansively.
Lack of diversity in COVID-19 clinical trials
Researchers conduct clinical trials to determine the safety and effectiveness of a new drug. However, it is difficult to guarantee that the effects of a treatment strategy will be the same across populations.
The new NEJM article comes in the wake of some complaints that many sponsors of COVID-19 clinical trials, including government agencies and pharmaceutical companies, have not conducted more diverse studies by race.
A team of researchers from the University of Georgia (UGA) and the University of Colorado and a pharmacist from Phoebe Putney Memorial Hospital in Albany co-authored the article.
They based the claim on an analysis of several remdesivir clinical trials in which the study population failed to include adequate representation of minority groups.
The researchers discovered that in the Adaptive Covid-19 Treatment Trial that tested the efficacy of the antiviral remdesivir, Black Americans made up about 20% of the total patient population. The National Institute of Allergy and Infectious Diseases carried out the trial, which received federal funding.
Additionally, in the Gilead-funded clinical trial of the drug, 11% of the patients given remdesivir were Black. Latinx and Native Americans accounted for 23% and less than 1%, respectively, of the federally funded trial. The Gilead-sponsored trial did not provide the proportions for these patients.
“The overwhelming majority of the patients in both of those large clinical trials were Caucasians,” notes Daniel Chastain, study lead author.
“Knowing that African Americans die at a higher rate than Caucasians, can I say that this medication will work in them as well? Yes, they enrolled a bunch of patients, and yes, they got these data out as fast as possible, but can we use this information to inform treatments in all patients?”
The remdesivir trials showed that patients who received the drug recovered from COVID-19 somewhat earlier than those who received placebos. However, people of color commonly experience more severe symptoms and complications from the disease.
The investigators also discovered that results supporting the efficacy and safety of remdesivir in minority groups “are limited.” The researchers indicate that such data is crucial for providing better treatment strategies for COVID-19.
“I think the hardest question to address is what’s the harm? I have no idea what the potential long-term complications of these treatments may be. We don’t know. That’s what makes me the most nervous going forward,” states Chastain. “We’re so prone, and we’re taught that you always have to ‘do something,’ but sometimes doing something is the worst thing to do in that scenario.”
Clinical trials need more minority inclusion to generalize results
Ideally, clinical trials should include people from communities that have the highest risk of contracting the virus. However, clinical trials have a long-standing problem of a lack of diversity despite the implementation of federal laws instructing the inclusion of minorities in government-sponsored research.
“The modest benefit seen in time to clinical improvement with remdesivir may not be generalizable to minority populations, given the differences in disease severity and outcomes,” the authors wrote.
The continuation of the problem in COVID-19 clinical trials has led the researchers to advocate for change. “Why aren’t we putting up infrastructure for clinical trial sites in areas that were heavily hit by COVID?” questions Chastain, who is also a clinical assistant professor of pharmacy at UGA’s Albany campus.
“If we would’ve included Albany, those clinical trials would’ve been more diversified and would’ve been much more representative of what the coronavirus pandemic looks like in our area and throughout the U.S.”
The authors recommended appropriate random sampling and the expansion of clinical trial sites to vulnerable communities with high-risk patients to better reflect the demographics of the ongoing pandemic.
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