CLINICAL TRIALS PROVIDE THE DATA needed to judge whether new cancer treatments are safe and effective. But if those trials don’t involve a diverse group of participants, many experts say we don’t get a full understanding of the treatments’ effects for the population at large.
A panel of researchers discussed the importance of diversity in clinical trials and outlined approaches they’ve studied for increasing recruitment among minority populations during the 16th American Association for Cancer Research (AACR) Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, held Sept. 29 to Oct. 2 in Orlando, Florida. (The AACR publishes Cancer Today.)
“When we develop knowledge … in an unbalanced population, what we are really doing is extrapolating new knowledge to populations we have not studied,” said Raymond U. Osarogiagbon, a thoracic oncologist at Baptist Cancer Center in Memphis, Tennessee.
During the panel, four researchers presented their work, which collectively identified the roles community health workers, community outreach and engagement, decentralized trials and community cancer centers can play in increasing clinical trial diversity.
Community Health Workers
Mona Fouad, a health disparities researcher at the University of Alabama at Birmingham (UAB), noted mortality rates for several cancers are higher in minority populations than among white patients, pointing to the importance of testing therapies in trials that are representative of all people.
Fouad referred to a study published September 2021 in JAMA Network Open that found under 10% of patients had been asked to join a clinical trial, with fewer than half of those going on to participate. In a separate study, preliminary results of which were published in Cancer in 2014, Fouad and colleagues interviewed clinical trial investigators, who acknowledged they had never been trained in patient recruitment and they lacked the time to address participants’ needs.
To try to remove these barriers, Fouad and colleagues at UAB trained community health workers to be clinical trial navigators who connected patients, the health care team and community resources. “This navigator really is linking all those three entities,” Fouad said.
The community health workers explained the clinical trial process to a largely African American population. “The education piece really, really helped,” Fouad said. “We empowered the patients to be asking about clinical trials.”
After community health workers joined the research team, 80% of eligible African Americans agreed to be in a trial, with 72% accepting support from a patient navigator. Researchers found 74% of those with the help of a patient navigator completed a trial, compared with 37% of those who did not receive patient navigation.
Community Outreach and Engagement
Lucile Adams-Campbell, an epidemiologist at Georgetown Lombardi Comprehensive Cancer Center in Washington, D.C., is the principal investigator of the National Capital Area Minority/Underserved National Cancer Institute Community Oncology Research Program. The program operates clinical trials in an area with a population that is 48.3% Black and 10.6% Hispanic. Since its inception four years ago, the program has enrolled 461 patients in clinical trials, with 62.9% being members of minority groups, according to Adams-Campbell.
To reach that benchmark, the cancer center has emphasized community outreach and engagement. “Patients come from the community,” Adams-Campbell said. “We need to make certain that we are engaged in our communities.”
Under the guidance of a community advisory council, the center employs patient navigators, health communication specialists and clinical trial recruiters to make the enrollment process easier, according to Adams-Campbell. The staff itself is also diverse, including people who are bilingual, identify as LGBTQ+, have lived in public housing, and are members of racial and ethnic minority groups.
For outreach to be effective, Adams-Campbell said, cancer centers must do three things. First, they must leverage a diverse advisory council to form connections with the community. “You get people to buy in,” she said. Secondly, centers must be prepared to address all social determinants of health. “You have to be able to follow through,” she said. Lastly, centers must take an active role in clinical trial design.
Many current clinical trial practices help “perpetuate the burden to the already disadvantaged, unrepresented populations and sometimes put into question the generalizability of the results of these trials,” said Joaquina Celebre Baranda, a medical oncologist at the University of Kansas Cancer Center in Kansas City.
Baranda’s research focused on diversity in phase I and II clinical trials, which evaluate the safety and efficacy of new drugs and try to find the optimal dosage. Compared with later-stage trials, Baranda noted, these trials can require longer clinic visits and often are offered only at large cancer centers in metropolitan areas—factors that can prevent people in underrepresented groups from participating. “Inequity in clinical trials is more profound in early-phase clinical trials, and we have to understand these barriers,” she said.
Baranda’s team at the University of Kansas Cancer Center participated in the National Cancer Institute-funded Create Access to Targeted Cancer Therapy for Underserved Populations (CATCH-UP.2020) grant program, initial results of which were published February 2023 in JNCI Cancer Spectrum. They identified 28 tools that could help increase enrollment among underrepresented patients.
While the tools included approaches like increased patient navigation and education for outreach staff, many helped decentralize trials. Investigators used telemedicine to decrease required in-office visits and allowed participants to receive the experimental treatment from local oncologists, reducing the amount of travel needed. “CATCH-UP taught us that we can bring these trials close to home for our patients,” Baranda said.
After implementing these protocols, trial accrual increased and mirrored the makeup of the overall patient population, with 55% of participants coming from underserved groups, Baranda reported.
Community Cancer Centers
Bringing trials closer to home was also a key theme for Osarogiagbon. He noted that 85% of cancer care occurs in community health care systems, which often do not offer clinical trials. “If we lock them out of our clinical trials enterprise,” he said of people treated for cancer in these systems, “we are shooting ourselves in the foot because we struggle to complete a lot of our clinical trials.”
Osarogiagbon referred to a 2019 review in the Journal of the National Cancer Institute that found academic cancer centers’ clinical trial enrollment rate was more than double that of community cancer centers. When analyzing why that occurred, the review found the two populations had no differences in patients meeting eligibility criteria or patients’ desire to participate. The community cancer centers simply did not have clinical trials for their patients to enroll in. “The biggest barrier … is there are just no clinical trials in the places patients go seek care,” Osarogiagbon said.
Osarogiagbon said the same review found 56% of potential participants did not join in a clinical trial because there was no trial offered for their cancer where they received treatment. Of the remaining 44%, half did not meet the eligibility criteria, leaving just 22% of patients whom investigators could talk to about trial participation. A 2021 review in the Journal of the National Cancer Institute found 55% of patients agreed to join a trial if offered the chance, with no differences based on race.
“Meet the people where they are,” Osarogiagbon said, stressing researchers need to offer clinical trials where most patients receive care.
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