As the triple threat of COVID-19, RSV, and influenza surges this winter, and new treatments and vaccinations are being developed and administered across the country, attention around the importance of clinical trial participation has resurfaced. Who are these treatments safe and effective for?
Black participation in clinical research historically has been and remains lower than it should, said Dr. Kevin Sneed, dean of the University of South Florida’s Taneja College of Pharmacy. In 2020, Black Americans represented about 8% of clinical trial participants, according to the Food and Drug Administration — up 1% from a similar FDA report that looked at 2015-2019.
Although there have been many significant innovations in health care technology and advancements in medical treatments over the past few decades, Sneed said the consequences of the gap in representation means many Black folks are dependent on medications and health devices that have not been studied and proven effective for their racial group.
Race, ethnicity, age, sex, and weight are among the factors that can affect how people respond to the same drugs, devices, or medical treatments. In order to ensure these are safe, diversity in clinical trials allows researchers to account for diverse lived experiences and different community exposures.
A report published in the fall by the Pew Research Center examines Black Americans attitudes about participating in clinical trials and adds nuance to the discussion of why representation in trials is lower among Black folks.
Despite lower levels of participation in clinical trials, a majority of Black adults see them as very important, although it is a slightly smaller share than the nearly 70% of White adults who say the same, according to the report. Overall, about two-thirds of all U.S. adults say clinical trials are very important. But the responses from Black people interviewed for the report shows that whether clinical trials are important is only part of the story.
One woman asked the Pew researchers why it has to be her to volunteer. “Black women in general in the U.S. have to do so much,” she said, “why can’t just, this one time, someone else volunteer for this research study that would enhance the importance of research as a whole?”
Others, whose names and exact ages are being protected by Pew for research purposes, expressed concern over the uncertainty around being the first to receive new treatment.
“This is my body and I don’t really know what you’re testing on me,” said a Black man between the ages of 25-39. “I don’t want to take the risk. It’s unknown for me.”
Another woman around the same age added: “I believe in science, I do my part, but I’m not participating in that.”
With a limited number of willing participants, diversity within trials suffers.
“The challenge is if we don’t have representation, then it’s hard to know whether these new medicines are safe or effective for Black Americans, since they’re mostly tested on white Americans,” said Cary Funk, a lead author on the report and director of science and society research at the center.
There are some people who would be willing to participate if informed about clinical trial opportunities and asked to participate.
“I’d do it because I think they help people, in the long run. It can help somebody, so I have no qualms with it,” said one Black woman age 40-65.
It is important that concerns are addressed upfront, health equity experts say. Researchers often assume the nonconsensual medical experimentation on Black people through history is the main reason for distrust, most often citing the Tuskegee experiment, during which Black men were intentionally denied treatment for syphilis beginning in the 1930s.
Instead, the hesitation spans a wide variety of reasons, including current medical mistreatment.
A majority of Black adults have had at least one negative experience with a health care provider, according to a report from April. And among Black women, the numbers are even more grim. For those women ages 18 to 49, more than 70% said they’ve endured at least one negative interaction with a health provider, including dismissal of their pain.
“In reality, many younger populations have either not heard of or are not fully aware of the impact of the Tuskegee study,” said Sneed. Instead, the trauma has been passed down through generations, he said. And the reasons Black folks do not participate in clinical trials are more complex than notorious experiments on Black Americans.
Sneed runs a program called WE-CARE, which aims to improve health outcomes among minority groups by increasing enrollment in research and improving trust between the community and researchers in the Tampa Bay area.
Often, he finds there is a lack of understanding around what the process of clinical trials includes as well as barriers to being able to participate and getting the word out to Black communities about trial recruitment, he said.
The solution requires work from a variety of parts within the health care system, he said: from holding researchers accountable to diversifying their trials to getting health care providers in Black communities involved in education and recruitment.
In recent years, the FDA, which approves new drugs and treatments, has made it clear they have an expectation for diversity in clinical trials, although they have yet to mandate it.
“I am very encouraged about where we can go,” said Sneed, “but it will require an enormous amount of effort.”
If you or someone you know might be interested in participating in clinical research near you, a list of studies in your area can be found at http://www.clinicaltrials.gov/