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Fred Hutch study finds race, sex disparities in COVID trials

Dec 7, 2022, 11:37 AM

Covid Vaccine...

CHICAGO, ILLINOIS - SEPTEMBER 09: A pharmacist prepares to administer COVID-19 vaccine booster shots during an event hosted by the Chicago Department of Public Health at the Southwest Senior Center on September 09, 2022 in Chicago, Illinois. The recently authorized booster vaccine protects against the original SARS-CoV-2 virus and the more recent omicron variants, BA.4 and BA.5. (Photo by Scott Olson/Getty Images)

(Photo by Scott Olson/Getty Images)

A study conducted at Seattle’s Fred Hutchinson Cancer Center found that the nation’s COVID vaccine and treatment trials did not accurately match the population when it came to diversity.

The study, which was published this week in JAMA Internal Medicine, looked at more than 100 trials done across the country, involving more than 175,000 patients in total.

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The researchers found inequities among races and sexes, with some groups represented disproportionately.

“We found good representation of Black patients and Asian-American patients in treatment trials for COVID-19, but less so for prevention (vaccine) trials,” explained Dr. Joseph Unger, an associate professor of biostatistics at Fred Hutch and the study’s senior author.

Inversely, “We found that female participants were under-represented in treatment trials, but were well-represented in prevention trials,” Unger said.

Unger and his colleagues have some idea of why the numbers turned out this way.

By definition, people in treatment trials had to already be hospitalized with COVID, and Unger pointed out that COVID tended to hit communities of color especially hard. Participation in a vaccine trial, however, is more likely to hinge on a patient seeking out the trial. Unger said that several factors may stop a person from a disadvantaged community from seeking out a vaccine trial, such as lower access to health care, inability to take time off work, a lack of transportation, or simply not finding out about the trial.

As for why the percentage of women in treatment trials was lower than their portion of the population, the researchers believe this may have to do with early misconceptions about COVID treatment and pregnancy.

“There was a sense, especially at the beginning, that we had to be careful around issues of pregnancy and maternal health. The women themselves may have been less likely to participate in a treatment trial,” Unger said. “But there’s also the case that men, especially older men, were predominantly harder-hit at the beginning.”

The researchers found that federally-sponsored trials did a better job of reaching more diverse groups of people than the tests run by the private sector.

In the future, Unger said, pharmaceutical companies conducting trials need to make more of an effort to go out into the communities, including lower-income neighborhoods, to seek out patients.

“You have to do a better job of bringing the trials to the patients, rather than expecting the patients to come to the trials,” Unger said. And this needs to happen “not just at the large academic centers, but out in the community, where most patients receive their care.”

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