Narrowing the Diversity Gap in Cancer Clinical Trials: Breaking Down Barriers and Building Trust

Black individuals make up 13 percent of America’s population yet, on average, they represent 5 percent of clinical trial participants. (Photo courtesy: Unsplash.com)

In 2020, the Food and Drug Administration (FDA) approved Sarclisa, a drug designed to work with one’s immune system to kill the cells that cause multiple myeloma. Multiple myeloma, blood plasma cell cancer, is twice as common in African Americans when compared to white Americans.

One percent of people in Sarclisa’s clinical trial were Black or African American while 80 percent of participants were white, according to the FDA’s Drug Trials Snapshots Report, which shows the demographic breakdown of clinical drug trial participants.

Sarclisa’s clinical trial illustrates how people in the Black community are being left behind when it comes to cancer research even though they carry one of the heaviest cancer burdens. According to the American Cancer Society, incidence rates of cancer in Black men are 9 percent higher and death rates are 22 percent higher when compared to white men. Although Black women are less likely to be diagnosed with cancer than white women, they have a 13 percent higher death rate.

Black individuals make up 13 percent of America’s population yet, on average, they represent 5 percent of clinical trial participants. Clinical trials are the gateway to making discoveries and advancements in medicine a reality. Participating in clinical trials enables more frequent medical care as well as early access to potentially lifesaving or life-extending treatments.

Minorities are missing out on the numerous benefits of clinical trials. Clinical trials have multiple phases, and they often take years to complete, explains Chasity Washington, executive director of the Center for Cancer Health Equity at The Ohio State University Comprehensive Cancer Center (OSUCCC). “That’s years where those that are not part of the study [minorities] aren’t getting that gold standard of care,” says Washington. “And if it’s improving [patients’] outcomes for those on trial then those who are not getting the treatment, often minorities, are not benefiting—it widens the gap in cancer health disparities.”

At the OSUCCC, public health and medical experts are going out into the community. They are educating underserved populations and building trust to weaken systemic barriers and bridge the minority gap. Over the past five years, their pivotal work has created a 33 percent increase in African American participation in their Interventional Therapeutic Trials at the OSUCCC.

Omitting minority groups in clinical trials is not “good science,” explains Dr. Jonathan Jackson, the executive director of Community Access, Recruitment, and Engagement Research Center at Massachusetts General Hospital, in a ProPublica article from 2019.

According to the FDA, drug effectiveness and drug reactions may vary by age, gender, race, and ethnicity. Nicole Cohen, US Head of Patient Recruitment and Retention at Boehringer Ingelheim Pharmaceuticals, stresses that a study’s participants should mirror the population being treated for the disease. Failing to do this “can spell incorrect dosing, higher incidence of adverse events, decreased efficacy, interactions with [other] medications, and more when the compound is approved,” says Cohen. “The generalizability is inaccurate. In addition, having the salient populations underrepresented in the data speaks to and perpetuates a larger health equity issue.”

Since the 1980s, studies have found clinical differences in drug response and effectiveness among races and ethnic groups. For instance, a 1982 study from the Veterans Affairs Cooperative Trial found propranolol (a beta-blocker) was more effective in lowering blood pressure in white participants compared to Black participants while hydrochlorothiazide (a diuretic) was more effective in lowering blood pressure in Black participants than white participants. Another study from 2013 by Bachtiar and Lee noted adverse drug events may be more common in certain populations. For instance, Black Americans taking 5-Fluorouracil, a chemotherapy drug, developed a higher rate of hematologic toxicities, such as leukopenia (decreased white blood cells) and anemia (decreased red blood cells), compared to those of European ancestry.

According to the FDA, drug effectiveness and drug reactions may vary by age, gender, race, and ethnicity. (Photo courtesy: Pexels.com)

The road to enhanced clinical trial diversity is marked with countless barriers. Many of these barriers align with a person’s social determinants or the condition of one’s environment (where they live, work, play, and pray) that affect their health. Economic instability, limited education, decreased access to quality health care, social stressors, and unsafe neighborhoods make leading a healthy lifestyle and joining clinical trials challenging. Additional barriers to minority participation are mistrust of the health care system stemming from decades of racial exploitation and the implicit bias of health care providers.

Washington and her colleagues believe patient navigators, who help guide patients through the health care system by facilitating communication with health care providers and providing social, financial, and legal support, are a critical first step in creating cancer health equity. “When you talk about cancer health disparities, a lot of it is social determinants. Once you can help address those, then we can see us all on the same playing field,” says Toyin Adeyanju, program manager at the Center for Cancer Health Equity at the OSUCCC. “Our patient navigators go beyond their job,” she says. “To us [people in the medical field], your health would be our number one concern, but if your basic needs aren’t being met how can I talk to you about cancer screening when you’re worried about being able to pay rent this month.” Adeyanju considers patient navigators to be the keystone strengthening the bridge of trust between patient and clinic.

One of the significant barriers to participation, Adeyanju believes, is the lack of communication between patient and physician. People in the Black community may not be joining clinical trials because health care providers have not informed them about current studies and how these studies may help their prognosis. The Association of Clinical Research Professionals (ACRP) notes that health care providers might not ask their Black patients about clinical trial participation because of bias: they may assume their patients will have difficulty following the directions of the study, will have difficulty attending appointments, or will be distrustful of the researchers.

“If people are asked and explained to in a manner that they understand, Black participants will participate,” says Washington. The OSUCCC is determined to improve communication and education regarding clinical trials. “We are working on strengthening ways in which we ensure that every patient is asked and that if they don’t go on [the study], we’re tracking why not. Because if it’s a barrier or something we provide support to address or fix, we want to be able to do that.”

Washington and Adeyanju emphasize further diversification of the research and health care field is also a way to help bridge the minority gap in clinical trial participation. In attempts to diversify the pipeline of clinical researchers, the OSUCCC created a summer research internship in partnership with Wilberforce University and Central State University—the two historically Black colleges and universities in Ohio. During this ten-week program, undergraduate students create a research question and work with a mentor to conduct research.

“I think the key to helping reduce the disparities is getting more people that look like the affected population out there serving the community, working, researching to figure out what we can do to change this,” says Adeyanju who works closely with the students during those ten weeks. “They’re the future.”