Expanding clinical trial diversity requires ‘showing up’ in the community to build trust
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Limiting eligibility criteria, recruiting trusted community messengers and reducing financial burdens can help improve diversity of clinical trial enrollees, a panel of professionals said during a Friends of Cancer Research webinar.
They all stressed the importance of engaging the community and building trust to narrow the gaps in research.
“We have to create a lot of easy buttons for folks in order to participate meaningfully in these clinical trials,” Edward S. Kim, MD, MBA, FACP, FASCO, an associate medical editor for Healio | HemOnc Today, and vice physician-in-chief and professor in the department of medical oncology and therapeutics research at City of Hope National Medical Center, said.
About 8% of adults with cancer participate in clinical trials, according to background information provided by the event’s organizer.
In 2022, white patients made up most of those trial populations, Rep. Anna Eshoo of California said in her opening remarks. Additionally, experts deemed just two diversity plans out of all those submitted to the FDA Center for Drug Evaluation and Research in the past year as acceptable.
“Patients and their families should not have to wait any longer to be part of life-changing clinical trials,” Eshoo said.
However, the panel stressed there is no singular strategy for achieving diversity. Broadening clinical trial populations is a multifaceted problem.
Lucy J. Gansauer, MSN, RN, OCN, CCRP, diversity, equity and inclusion champion at SWOG Cancer Research Network, emphasized “intentionality” when attempting to build diverse cohorts.
“Where you see a shortfall, do specific engagement with those populations,” she said.
Being present in underserved communities is critical too.
“You have to show up in your community,” Kim said. “What’s really important is the faculty and the staff that you hire are representative of these communities.”
Kim noted the importance of taking part in community events.
Being active builds trust, which helps connect those in health care with leaders in communities that can disseminate information on the benefits of clinical trials.
Kristi Mitchell, MPH, co-founder and principal at Atlas Clarity LLC and Health Equity Outcomes, detailed how valuable faith-based leaders and local health workers are in helping to build that trust.
Staying updated on cultural-sensitivity training and routinely collecting social determinants of health data also foster better relationships.
Mitchell suggested bringing together a board of community leaders from academia to health centers to faith-based institutions to improve health care overall in these communities.
“That’s their No. 1 priority,” she said. “It is not to be a part of your trial. It is to get the health care they are actually looking for.”
Changing perceptions in health care research can also improve diversity in clinical trials.
Trail sponsors need to reduce the number of eligibility criteria required to participate, Kim said.
“We are overcomplicating our studies,” he said.
“It is very important to keep patients safe. It’s important to make sure we monitor safety and side effects, but we don’t need that many eligibility criteria,” Kim added. “The more eligibility criteria you tack onto a study, the less number of people can be included in that study. That inherently is discrimination.”
Clinical trials can often have 40 criteria to be enrolled. Kim suggested at most 20, although he dreams of a day when it is as few as 10.
Researchers should be aware that seeking a diverse population does not necessarily mean that developing a study cohort will take longer.
Nicole Richie, PhD, vice president and global head of health equity and population science at Genentech Roche, described how partnering in the right locations could speed up enrollment.
“One of the things we battle against is this myth that trying to have more representative patient populations will slow down enrollment,” she said.
“We hear this all the time from a sponsor perspective,” Richie added. “But what we’ve actually shown with our inclusive research site alliance is not only do these sites accrue 60% to 80% more representative patients than their study peers, they also do it three times faster.”
Having willing participants is not the only factor in having diverse study populations. Gansauer discussed how financial stipends can reduce patients’ burdens in participating.
“More importantly, I think it puts us on a trust relationship,” she said. “It’s not all about what you’re giving us to do this clinical trial, but a partnership with the patient.”
It is up to the medical side to ensure all patient populations are cared for.
“We have to build trust by the care we deliver,” Kim said. “We got to back that up. If we’re going to be out there showing up, then we have to make sure that we deliver on our side.”
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