Clinical trials need more participants from Black and brown communities. But has medicine earned their trust?
“As cancer survivor, I see these types of initiatives happen often. But after a while, they tend to fizzle,” Henrietta White-Holder said.
White-Holder and I were sipping Shirley Temples in a hip and stylish speakeasy, Needle and Thread, a Black-owned social spot in Providence, last fall. With fun music, loud chatter, and delicious fries, it was hard to believe that we were at a cancer clinical trials outreach initiative.
Trust is a recurring theme in conversations about the inclusion of people from minoritized groups in clinical trials. Between historical incidents that demonstrate the ways the medical establishment has harmed generations of people and persisting modern-day health inequities, there is little evidence that medicine has earned the trust of these communities.
Warm, welcoming outreach events that focus on community, rather than the typical PowerPoint presentations by white-coated researchers, could turn things around. “When I heard Sheldon Holder was behind this,” White-Holder told me that night, “I had to be here.”
Oncologist Sheldon Holder, MD, PhD (no relation to White-Holder), created Color of Cancer in October and celebrated its launch with the speakeasy event the following month. The initiative is a community-based outreach effort, based at Brown’s Legorreta Cancer Center, to build relationships and earn the trust of people of color. Color of Cancer’s goals are to share the stories of Rhode Islanders of color and their experiences with cancer through a series of short films—and to increase their participation in cancer clinical trials ( See Medicine@Brown, Winter 2024).
“As a cancer specialist, I believe the best therapy for a patient is to be treated in a clinical trial,” Holder explained to the lively crowd at Needle and Thread. “When we’re testing new drugs, we think it’s best to test it on the entire population to make sure it works as well for everybody, and it’s a problem if people in the clinical trials are not as diverse as the country.”
Racial and ethnic minorities comprise 39 percent of the US population. But they account for just a fraction of clinical trial participants. For cancer clinical trials, less than 10 percent are people of color, despite the fact that the National Comprehensive Cancer Network considers participation in clinical trials the best management for any patient with cancer. Government officials and public health experts often lament that clinical trials don’t reflect the diverse population of patients and call for action to tackle these disparities.
While researchers and clinicians are hearing the “call” loud and clear, what does effective, intentional, and compassionate action look like?
“Usually when cancer centers try to engage with the community, they set up stalls and fairs—we try to educate people,” says Holder, an assistant professor of pathology and laboratory medicine who treats genito-urinary cancers and investigates potential novel therapies. He and his colleagues are among many groups nationwide that understand the lifesaving implications of diversifying clinical trials and are acting on it. “We should have a different approach. A statistic is not enough, information is not enough, data is not enough. What we need are relationships. So we said, let’s focus on relationships.”
A History Of Abuse
Decades of mistreatment by the health care system have long undermined the trust of minoritized and marginalized populations. Take, for example, the US Public Health Service’s syphilis study in Tuskegee, AL, which withheld treatment from Black men long after the availability of penicillin. Then there was Enovid, the world’s first birth control pill, which was tested on Puerto Rican women who were not informed of the risks of the drug’s high hormone levels; three women died.
These high-profile injustices are just two of the countless well-founded reasons why many people of color have such a poor view of medical testing and distrust the motivations behind it. “Those are things that don’t go away very easily, and they’re passed on from person to person and it creates an incredible level of mistrust,” says Pablo Rodriguez, MD, a clinical associate professor emeritus of obstetrics and gynecology.
As an ob/gyn, Rodriguez is no stranger to requests from researchers for help in finding patients to enroll in studies. But, he says, “they could never get enough people to participate in clinical trials, especially people of color, simply because there’s a mistrust of the medical establishment. It’s a history of abuse, a history of experimentation without consent, forced tubal ligations, all sorts of things that people still remember that made them distrust the medical establishment.” Not only is there the barrier of mistrust, but of language. “I can’t tell you how many times my Spanish-speaking patients were told by somebody, ‘you better speak English,’” Rodriguez says. “So they feel devalued, they feel not listened to, and they don’t want to be a guinea pig.”
A statistic is not enough, information is not enough, data is not enough. What we need are relationships.
Things like travel, paid leave from work, time commitment, and complex protocols can all hinder patient enrollment as well. “Clinical trials just aren’t an option for many people when they have to travel long distances and take time off of work to participate. As researchers, we have to go to their communities. We can’t expect them to come to us,” Monica Bertagnolli, MD, director of the National Institutes of Health, said in a Q&A for the National Cancer Institute’s National Cancer Plan.
These challenges have influenced recent efforts by the American Cancer Society, NCI, and others, which include centralized hubs such as the NIH’s Coordinating Center for Clinical Trials and increased funding and grant awards for scientists throughout the country. Color of Cancer was made possible by a grant with similar objectives. Holder, associate director for diversity, equity, and inclusion for the Legorreta Cancer Center, is one of three investigators at Brown who received a Robert A. Winn Diversity in Clinical Trials Award from the Bristol Myers Squibb Foundation in 2021 to increase diversity in clinical trials and to transform the clinical research landscape.
Institutional Change
Another such effort is happening at Brown and Rhode Island Hospital, led by Ghada Bourjeily, MD, and Sharon Rounds, MD. Through the Advance Rhode Island-Clinical and Translational Research program, Bourjeily and Rounds are site principal investigators of the IDeA State Consortium for Clinical Research Resource Center site in the Ocean State.
“The overarching goal of this grant is to increase the funding for clinical trials within the state,” says Bourjeily, a professor of medicine and of health services, policy, and practice.
And “to represent participation by groups that might not otherwise be participating in clinical trials, such as underrepresented ethnic or racial minorities,” adds Rounds, associate dean for translational science. She and Bourjeily plan to do this with two initiatives: a clinical research coordinator development program and a clinical trials service center.
Investigators at Rhode Island Hospital, for example, are routinely contacted by independent organizations across industry and government sectors to join clinical trials. The challenge lies in the inefficient and decentralized nature of this outreach, as well as limited scope, since these independent parties are not taking full advantage of the existing expertise and infrastructure within local institutions. For these reasons, Bourjeily’s chief aim is to improve communication, specifically “our own communication with investigators. We currently have no formal inventory of clinical researchers or their content area of expertise.”
Improved communication between these parties will allow for the diffusion and proliferation of trial opportunities, promoting intentional outreach to specific investigators to lead the trials. However, another challenge is that there are not enough trained clinical coordinators to facilitate the trials, nor are there training programs in Rhode Island to develop this type of workforce. The clinical research coordinator development program aims to rectify that.
The program includes didactic components and one-on-one time with at least one preceptor, who will teach trainees general trial research skills as well as local methodology and software or institutional review board requirements unique to Rhode Island institutions. The grant’s immediate goals are to test the training program and develop current personnel to embrace existing trial management engines, which track all clinical trials, people involved, and progress made, “so that [it]can be implemented across the board,” Bourjeily says.
Rhode Island Hospital serves as a testing ground of sorts for this framework, “where we need to figure out potential challenges and obstacles, and ways to address them. But we definitely need to expand more,” Bourjeily says. “We need to be able to capture more people that are from underserved areas distant to Providence that may not be participating in research … because the more diverse our participant pool is, the more generalizable and applicable the research is.”
Intentional Recruitment
Despite the widely shared goal of diverse patient populations, current recruitment methods are often homogenous and monolithic, experts say.
An investigator’s first step should be to consider on which groups to focus their recruitment efforts, so that the population within a clinical trial represents the distribution of the disease as it occurs in the population. To achieve that, “it’s about being intentional” versus reactionary, says Don Dizon, MD, the vice chair of diversity, equity, inclusion, and professional integrity at SWOG Cancer Research Network, which designs and conducts clinical trials.
“Intentionality is when you actually go and say, ‘I am interested in this disease, let me find out who is impacted by it in the US,’” says Dizon, the director of medical oncology at Rhode Island Hospital and a professor of medicine and of surgery. “Then you look at the proportionality of that disease in different populations, and use that to generate what you would like to see [population-wise] in clinical trials.”
Instead of taking a “check-the-boxes” approach, where every study or clinical trial has the same level of diversity, researchers need to deeply understand the disease at hand and those most vulnerable to it. This will inform targeted recruitment of those vulnerable groups and avoid wasting resources on recruiting. “The goal is to get a steady population that looks like the population at large,” Dizon says. “If you do that from the start, then that also drives how you recruit.”
Targeted recruitment may mean rethinking even the fine print of recruitment and informed consent materials. “Say there is a Chinese woman in my clinic who is a candidate for this trial, but this consent form is not in Chinese,” Dizon says. The process can be made more accessible if, for example, consent forms use “language that will make sense to people with a fifth-grade reading level in English, or even having consent forms in Chinese, or doctors who can speak to patients in their native language.”
Pablo Rodriguez has seen similar issues in the Spanish-speaking population. He has been a beloved radio show host on Latina 100.3 FM, the largest Spanish-language station in Rhode Island (which reaches as far as southeastern Massachusetts and Connecticut), for 38 years. During the pandemic, Rodriguez realized that his reach could be larger than radio and podcasting. “As I researched ways of reaching out to the population, I discovered that social media is really the most important way to reach the Latino community, and that the level of misinformation in Spanish is absolutely incredible,” he says. “So I said, I need to do something about this.”
In the US, adults identifying as Hispanic have the lowest health literacy of all ethnic groups. “If you have what is considered basic health literacy, you probably can’t even read a prescription or understand instructions,” Rodriguez says.
Rodriguez began posting health information on Facebook once he realized its popularity with Spanish-speaking communities. “Latinos spend more time on the radio than any other ethnic or racial group,” he says. “The second one is social media: Facebook, Instagram, YouTube.” Rodriguez realized that as a well-known, “trusted figure” in Rhode Island’s Spanish-speaking community, he could ensure they got accurate health information—and invite them to participate in clinical trials.
This was the catalyst for his start-up, Nuestra Salud, which aims to centralize a plethora of comprehensive medical information into a web repository. “I took it upon myself to just basically grab whatever information I could get from the hospital websites about clinical studies [and]I translated them,” Rodriguez says.
“No one wakes up and says, ‘oh, I’m going to look for information about clinical trials.’ That’s not how it works,” he adds. Everything about Nuestra Salud’s website (nuestrasalud.com) is intentional: patients won’t search for clinical trials, but they will seek information about a disease. When searching for and learning about diabetes, for example, they’ll find information about relevant clinical trials, with points of contact, that Rodriguez has purposefully sandwiched in between sections.
What upholds intentionality is interest and care, Rodriguez adds. He advocates for a more diverse and representative researcher and physician workforce, because “outreach for clinical studies has to be personal and it has to be culturally appropriate and it has to be something that people will find value out of it, that they don’t feel used, that there’s something in it for me or for my family,” he says.
Faith-based community engagement and recruitment efforts take a similar approach. For the US POINTER study, which is investigating lifestyle interventions to reduce Alzheimer’s disease risk, researchers at Brown and Butler Hospital partnered with religious leaders in Providence to increase the Black community’s participation. As Rev. Dr. Lamonte Williams, the study’s faith engagement leader, says, this model seeks to “put African Americans at the table, and not on the table.”
No one wakes up and says, ‘oh, I’m going to look for information about clinical trials.’
Different communities have different social patterns and figures of authority; there is no such thing as a “one-size-fits-all” recruitment approach. Katrina Byrd F’22, MD, a collaborator on US POINTER, says, “In the Black Christian community, news travels by word of mouth. Talking to people in a congregation is an opportunity to also reach their friends and family members who don’t go to church.” The study, which completed enrollment last year, recruited nearly 30 percent of its participants from underrepresented communities, according to the Alzheimer’s Association, which is funding the study.
Yet another inroad could be through physicians eager to give their patients access to treatments when no other options are available. Pulmonologist Corey E. Ventetuolo, MD, MS, director of the Center for Advanced Lung Care, cares for many young women from marginalized groups who are predisposed to rare and advanced lung diseases that can present during or after pregnancy. While there are many approved therapies, none is curative, and access to approved medications can be limited for patients who face barriers to health care.
Ventetuolo, an associate professor of medicine and of health services, policy, and practice, describes one patient with pulmonary arterial hypertension who enrolled in a clinical trial of an investigational therapy that is only available in a few centers. “It worked, it actually worked,” she says. The patient is continuing the treatment under an open-label extension until it receives FDA approval.
Ventetuolo, who grew up in Cranston, adds, “It is really important to me to serve my community and improve access to care as a native Rhode Islander.”
Compassionate Outreach
Authentic connection with the community is one of Sheldon Holder’s main strategies. As part of Color of Cancer, he formed an advisory board composed of members of the community, from policemen to cancer survivors to DJs, to tell him and the Legorreta Cancer Center how to best engage with Rhode Islanders.
Board member Candace Harper is an executive director of a Providence nonprofit and works on initiatives addressing food and housing insecurity. Harper says she accepted an invitation to join the advisory board due to personal tragedy—a grandmother, a grandfather, and her father all died from cancer. Her family has been in Rhode Island for generations; advising Color of Cancer is one way to give back.
“It’s so great when you can ask different pockets of the community, ‘Hey, what do you think about it?’” Harper says. “I think more people should do that. It just gives them a more genuine approach to the audience that you’re hoping to reach.”
But it can be a challenge to make events about a deadly disease fun and enjoyable, she acknowledges. “Nobody wants to come to a program where we’re just going to be talking about cancer,” she says. “You’ve got to go where the Black and brown community is living, moving, breathing, enjoying life, and just see if you can provide information where the people are.”
The Color of Cancer launch party at the Providence speakeasy last fall was the first of several informal gatherings Holder and the board have organized, including a series called Cancer Talk Cafés, where Rhode Islanders can meet and talk with Legorreta Cancer Center clinicians and cancer survivors. The café in February, hosted by the Cape Verdean American Community Association in Pawtucket, included the screening of a short film about a local cancer survivor and a potluck brunch. More than 30 people attended the event.
“People are more likely to change their behavior if someone they have a relationship with tells them that they should do something, rather than just because it’s good for their health,” Holder says.
Holder is just one of many researchers in Rhode Island proving that it is possible to diversify clinical trials by building such relationships, by meeting people where they are, and by rejecting the time-worn, one-size-fits-all model of clinical trials. Indeed, these scientists and physicians are demonstrating that research that embraces genuine community engagement can dismantle barriers and rewrite the narrative of medical research with empathy, understanding, and inclusivity.
