Minority patients underrepresented in Covid-19 trials despite greater willingness to participate, report finds
When Wanda McClain was working at Brigham and Women’s Hospital last March and April, she and other clinicians noticed something about the sick patients occupying beds.
“They were much more diverse than, you know, our traditional patients,” the former VP of community health and health equity said. “It showed very clearly the disproportionate impact that Covid is having on communities of color.”
What McClain observed in Boston is on par with numbers collected across the country. Black Americans are nearly three times more likely than white Americans to be hospitalized with Covid-19, and nearly twice as likely to die, the CDC reports. Hispanic or Latinx Americans are three times as likely to find themselves in a hospital bed, and more than twice as likely to die. And American Indian or Alaska Native community members are 3.5 times as likely to be hospitalized, and more than twice as likely to die.
Yet Black participants made up only 9.7% and 9.8% of Moderna and Pfizer/BioNTech’s Phase III vaccine trials, respectively — despite representing just over 13% of the US population. Hispanic or Latinx volunteers made up 20% and 26.2%, which is actually over census levels. But American Indian and Alaska Native volunteers? Just 0.8% and 0.6% of the trials, respectively.
“A lot has happened I think in the last 12 to 18 months, and we thought it was really appropriate at this point in time to really dig deeply into some of those challenges that have surfaced,” Clare Grace, Parexel’s first chief patient officer, told Endpoints News.
The Newton, MA-based CRO conducted listening sessions with physicians, interviews with the public, patient advisory council meetings, and a global survey to gauge perspectives on clinical trial diversity. And on Thursday morning, it published the results.
A key theme that emerged was trust, both Grace and McClain said — or rather, a lack thereof.
“This is before the vaccine was actually approved for emergency use, and I think we were in the midst of appointing people to the vaccine trials, so we were running up against those issues of trust and mistrust,” McClain said, who participated in a focus group with other physicians.
One interesting finding was that of 1,945 people surveyed in the US, Canada, UK, Australia, France, Hungary, Italy, Mexico, Poland and Spain, more non-white respondents said they’d be both willing to participate in a Covid-19 trial and take a vaccine. Yet in the US, communities of color are now getting vaccinated at much slower rates.
“I think what’s really important to remember is that, you know, different countries have different experiences around the pandemic in particular,” Grace said. “And so some of those countries have had very, very difficult times, whereas others have got more sophisticated healthcare systems and (are) generally a little bit more inclusive.”
When Brigham and Women’s set up Covid-19 testing, McClain noticed that people of color wanted to get tested, but were limited by a lack of information, or a lack of trust.
“It’s hard to have trust if people don’t know you,” she said.
So the hospital distributed information in multiple languages, and screened people for social determinants of health. They handed out bags of groceries at the test sites, and did things like screen for domestic violence.
“Really beginning to address those barriers that might limit someone’s ability to participate in the trial, that was a big piece of it — of earning their trust and educating them at the same time,” she said.
Other barriers discussed in the report include how much time it takes to participate in a clinical trial, or the transportation required to get to a trial site. Survey participants cited the number of required study visits as the greatest barrier, followed by visit duration, and payment for travel or for participation.
“Clinical trials, especially those within minorities and in certain areas, need to be accessible for those with limitations, both physically and financially. Many forget that even in this day and age not everyone has access to the internet or public forms of transportation,” an unnamed respondent said.
“Some women, some African American women, don’t have time to come to chemo because they have children at home that have to be cared for,” said Yasmeem Watson, a patient advisory council member. “They don’t have time to come to medical appointments. They would love to be cured and love to be healed, but sometimes it is beyond their control.”
Going forth, McClain says she wants to see biopharma companies hold themselves accountable, and develop robust community engagement strategies around “getting to know and investing in — and I’m using that word deliberately — making investments in those communities.” That means listening to patients, and creating programs for young people to build the next generation of diverse professionals.
“None of this is going to be done with a snap of the finger,” she said.
Social: via Parexel website