Most US clinical trials for coronavirus drugs and vaccines are still not enrolling nearly enough black and Latinx participants, new research shows.
Research a long history of focus on white Americans – but the inclusion of minority trial participants has perhaps never been so as important as it is amid the COVID-19 pandemic, which has taken a disproportionate toll on black and Latinx people.
Although vaccine developers have pledged to diversity in their trials, the data collected by the University of California, San Francisco, suggests that drug makers haven’t made good on their promises.
The new study that black Americans are under-represented in COVID-19 trials that have been conducted in all three major US cities – New York, Boston and Minneapolis – included in the study.
UCSF researchers found black Americans are under-represented in COVID-19 trials that have been conducted in all three major US cities – New York (green) Boston (black) and Minneapolis (blue)- included in the study.
In an ideal scientific study, the test subjects should be demographically the same as the real world group they are meant to represent.
So, if 99 percent of breast cancer patients are women, then 99 out of 100 participants in a trial of a drug to treat the disease should be women, and one should be a man.
In the case of coronavirus, about a third of people who have been infected are Hispanic, and 20 percent are black, according to data from the Centers for Disease Control and Prevention.
These numbers are not the same as the overall population. Hispanic people make up just 18.5 percent of the US population, and black Americans comprise 13.4 percent.
But since people of these races have been so disproportionately affected by coronavirus, public health experts believe it’s especially important that they be represented in clinical trials.
The UCSF team found that a major trial of remdesivir – currently the only authorized drug to treat severe COVID-19 – did not even include the races of its participants in its trial.
For the other five studies that had been published by July 10 and did collect data on race, the researchers compared the racial breakdown of their participants to racial breakdown of coronavirus cases in the cities where they took place.
In New York, for example, 33 percent of people who had contracted coronavirus by that time were Hispanic/Latinx.
This group was actually over-represented in research, with 51 percent of trial volunteers.
However, in Boston, just 17 percent of trial participants were Latinx, compared to 26 percent of COVID-19 patients in the city. In Minneapolis, 28 percent of coronavirus cases were in Latinx people, compared but just five percent of trial participants were Latinx.
Asian people were over-represented in trials in Minneapolis, but were not included in New York studies at all, and were under-represented in Boston.
Black Americans were under-represented in trials everywhere.
In Minneapolis, there were one sixth as many black people in COVID-19 treatment trials (making up five percent of volunteers) compared to their share of cases (33 percent).
Just 11 percent of people included in trials at New York sites were black, while 30 percent of COVID-19 cases were in black New Yorkers.
Boston did better, but still missed the mark with black people representing 38 percent of cases and 23 percent of trial participants.
Knowing that minority people make up an outsized share of coronavirus cases and deaths as well as a high proportion of people with ‘essential’ jobs in health care, service or that otherwise can’t be done from home, vaccine makers promised to make sure these groups were recruited to their safety and efficacy trials.
In late August, both Pfizer and Moderna announced that they had reached the halfway points of enrollment for their respective late-stage COVID-19 vaccine trials, which aim to enroll about 30,000 people a piece.
But only about a fifth of people who had signed up for the two monumental trials were black or Hispanic/Latinx.
According to an online registry of vaccine trial volunteers, just 11 percent of some 350,000 interested in participating are black.
That falls short of the 13.4percent of the US population that is black, and is nowhere near the 20 percent of people who have contracted the virus who are black.
Moderna announced that it would throttle its trial in an effort to recruit more black and Latinx participants, but they’ll need to substantially step-up their efforts to reach these communities.
‘Under-recruitment is the primary problem,’ UCSF study author Dr Hala Borno, told CBS.
‘I think if we invest in engaging with the communities we want to see enrolled in our clinical trials, then trust won’t be the barrier.’