By Jaymie Baxley
People of color, low-income populations and other marginalized groups are disproportionately affected by certain health risks, yet remain underrepresented in clinical trials and studies that shape medical practices.
The disparity can create inequities in care — something Chris Shank, president and CEO of the North Carolina Community Health Center Association, has experienced firsthand.
“I got sick about two and a half years ago, and I remember sitting in the doctor’s office and him telling me that they were going to put me on this medication,” Shank, who is Black, said in a recent interview. “The medication was designed for what I was there for, but my doctor wasn’t sure if it was going to work for me because there were no people of color in the research part of it.”
That’s partly why her organization is involved with THIS-NC, a new coalition that hopes to make health care research more inclusive through the involvement of “safety net” providers who work directly with historically underrepresented communities.
An acronym for Translational Health Institute of the Safety Net in North Carolina, THIS-NC launched in August with a ribbon cutting at First Choice Community Health Centers, a facility that serves low-income patients in Harnett County. Other organizations affiliated with the coalition include North Carolina Central University, the North Carolina Rural Health Leadership Alliance and the North Carolina Association of Free and Charitable Clinics.
The latter organization’s CEO, April Cook, is chair of THIS-NC’s board of directors. She said the 70 free and charitable clinics represented by her association cater to a largely uninsured population that “typically doesn’t have a voice.”
“They’re just not heard a lot of the time except within the walls of the safety net,” Cook said. “They have very complex challenges that they face on a daily basis, but they’re often not even included in the research.”
THIS-NC seeks to change that by bringing clinical trials and other studies to marginalized groups through providers they already know and trust.
Building trust
Becca Hayes, director of health research equity for the North Carolina Community Health Center Association, said one of THIS-NC’s goals is to encourage federal agencies to allow safety net providers to host clinical trials.
“The FDA and NIH are aware that the lack of diversity in clinical trials is a huge barrier, but they haven’t been able to figure out a good way to tackle that,” she said, referring to the federal Food and Drug Administration and the National Institutes of Health. “So instead of helicoptering in with a new program or a new provider to do certain things, why not just resource what’s already here and has been here for decades?”
Still, the coalition knows that making clinical trials more accessible to underrepresented groups doesn’t necessarily mean that members of those groups will participate in the studies. Hayes noted that “mistrust” of medical research is common in marginalized communities, especially among people of color.
Their misgivings are not without precedent. Unethical trials and experiments have been conducted on minority populations in the past, with the most infamous examples being the Tuskegee Syphilis Study on Black men in Alabama, or the use of cancer cells harvested from Henrietta Lacks without her consent and used widely throughout research without compensating her or her family.
“If you think about the history of clinical trials and certain populations over the years, there’s a real reason for that mistrust,” Hayes said. “Even if people are not completely aware of which study it was and what year it happened, it’s just ingrained — and it should be.”
Becca Hayes, director of health research equity for the North Carolina Community Health Center Association, during a kickoff event for THIS-NC. Credit: North Carolina Community Health Center Association
Overcoming that mistrust, she said, will require educating patients about laws that now exist to protect trial participants from unethical treatment.
“We want to make sure the community knows what their rights are and the risks and benefits so they can make that decision for themselves,” Hayes said.
Working together
Deepak Kumar, a cancer biologist and health equity researcher at North Carolina Central University, said the origins of THIS-NC can be traced to a $1.1 million grant the school received from NIH in 2022.
The grant was meant to help create a research network based in the state’s free clinics and federally qualified health centers that would focus on equity. Through this partnership, the university and associations representing the centers and clinics began looking at ways they could work together to address systemic inequities in health research.
“We don’t have billions of dollars,” Kumar said. “But we hope that if we join hands and come together, then we will be at least able to sit at the same table and advocate for our population.”
He said THIS-NC has so far received “an outstanding response” from “federal agencies and individuals in the government.”
“They have seen what’s happening, and they’re really excited that something at this level is being done,” he said.
The sentiment is shared by the coalition’s members, according to Cook.
“It’s very exciting for different reasons, depending on whose lens you’re looking through,” she said. “It’s exciting for the researchers. It’s certainly exciting for our providers, practitioners and clinics at the ground level.”
That excitement extends to Shank, who said she is looking at THIS-NC “through my own personal, lived-experience lens.”
“I’m really super excited about the possibility of bringing a diverse patient population to research that’s going to be done through the safety net,” she said. “That’s the ultimate way that we’re going to be able to enhance patient outcomes.”
Getting started
Hayes said THIS-NC has received funding from the FDA to “develop a national curriculum for safety net providers” who want to host clinical trials and other medical studies. The curriculum is expected to launch locally before being offered to providers in other states.
“We’re still in that labor-of-love phase,” Hayes said of the coalition. “We’re having success and we’re gaining momentum, but we’re also doing this for the first time and we’re trying to document what’s working well and what’s not so that we can be a model for others that want to try this.”
It remains to be seen what kind of trials and studies might eventually emerge from THIS-NC — and how willing patients will be to participate. Still, Cook believes the providers represented by the coalition are well positioned to reach communities that are too often overlooked in health research.
“Conducting a study in a safety net where people already trust us I think is going to open some doors that we haven’t been able to open in the past,” she said.
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