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A problematic diversity gap in clinical trials

Coronavirus Daily
Bloomberg

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A problematic diversity gap in clinical trials

At this point it's clear that Covid-19 isn't an equal opportunity threat: Black and Latino people have suffered far more than any other race. And yet, so far, in the rush to develop a vaccine or treatment for the virus, they have only accounted for a small fraction of participants in human trials.

More than 70% of participants in a late-stage Gilead Sciences trial of remdesivir, used to treat Covid-19, were White. Early-stage vaccine trials of Moderna's candidate that were led by National Institute of Allergy and Infectious Diseases were 89% White, and Pfizer and BioNTech's joint candidate was tested on a group that's 82% White.

This is a big problem — one that could potentially impact how well a drug eventually works for those that the virus has harmed the most.

That's because drug responses can be influenced by factors tied to race and ethnicity, such as genetics. One 2018 study, for example, found a genetic variant may be responsible for why the most popular asthma medication on the market, albuterol, often doesn't work for Black and Latino children.

A patient receives a shot in the first-stage safety study of a potential vaccine.

Photographer: Ted S. Warren/AP

More than that, diversity in research is necessary to understand the biological underpinnings of diseases that, for example, make some people more susceptible. Are minorities more likely to contract Covid-19 because they are more likely to be essential workers, or because they often live in more densely packed areas? Or is it something physiological? Without diverse clinical trials we have no way to know.

This isn't a new issue. The lack of minority participants in medical research has been a growing concern for years. Companies say that they aim to do better at attracting diverse trial participants in later-stage trials.

Persuading minorities to participate isn't always easy though, and only time will tell if those recruitment efforts pay off. Anthony Fauci, the head of infectious diseases institute, said Wednesday that it's pre-enrolled a pool that's 19% Black and 19% Latino.

Tulane University School of Public Health and Tropical Medicine Dean Thomas LaVeist told Bloomberg that the pandemic's scale means that even if just a small percentage of subjects have an adverse reaction to a drug or vaccine, that could mean millions of people.

"You need to have a study representative of the people actually using the drug," he said. "In this case, that's everyone."—Kristen V. Brown

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