How to build trust, improve diversity in clinical trial research
Key takeaways:
- Diversity in clinical research will improve outcomes for all people.
- Clinical trialists who reflect the community at large can more easily recruit diverse participants.
SAN DIEGO — People from underrepresented racial and ethnic groups participate in clinical trials at extremely low rates, and trialists have a duty to ensure participants reflect the larger community, according to a speaker.
Even as professional societies issue calls for equity in medicine, the lack of diversity in clinical trials persists, according to Janet Brown-Friday, RN, MSN, MPH, president for health care and education at the American Diabetes Association. Underrepresented racial and ethnic groups comprise nearly 40% of the U.S. population; however, 75% of the 32,000 participants in the trials of 53 novel drugs approved by the FDA in 2020 were white, Brown-Friday said.
“Certain drugs, devices, surgeries, behavioral and lifestyle are usually not available to underrepresented minority communities in the real world,” Brown-Friday said during a keynote address at the ADA Scientific Sessions. “Imagine a place where you could at least, for a time, have access to these interventions through research and have them possibly be free.”
In 2022, the National Academies of Engineering, Science and Medicine published a report on improving representation in clinical trial research that highlighted the difficulties faced by people often the most in need of interventions. That report touched on a painful history in clinical research that can be difficult to shake for some, Brown-Friday said. She cited a history that includes performing surgical procedures on enslaved Black women without anesthesia, the use of cervical cancer cells from a Black women for decades of research without compensation or the family’s consent, and the Tuskegee syphilis experiment that allowed Black men to go untreated for decades while being actively discouraged from seeking medical advice outside of the study.
Brown-Friday said acknowledging historical trauma from unethical trial practices is important, as is engaging grassroots and faith-based organizations in advocacy for trial participation. Trial staffers should also undergo formal training on cultural humility and implicit bias.
“The history of research in ethnic minorities shows prime examples of the barriers to diversity — the main barrier being mistrust of the medical community,” Brown-Friday said.
“To gain or regain trust, we must prove, through action, that we are indeed trustworthy.”
Access and availability also remain critical barriers to enrollment in clinical trials for people from underrepresented groups, Brown-Friday said, but several steps can improve participation of people from underrepresented groups. The first is to make sure diverse populations are well informed about the opportunity to be part of research that could be beneficial.
“The barrier of eligibility is also extremely important, and the researcher should review eligibility criteria that may actually exclude some diverse populations,” Brown-Friday said. “Where one conducts recruitment will impact the population recruited. Researchers must go into the community and speak directly to the population about their research. They must use plain language and avoid medical jargon. Hire staff that reflects the community they are looking to recruit.”
Trialists must also recognize cultural differences as a barrier to enrollment.
“Beginning with acknowledgement may be the first step to building trust,” Brown-Friday said.
Study retention begins at recruitment, Brown-Friday said, and trialists should make sure being a study participant does not add any financial burden.
“If transportation is an issue, use study resources to provide cabs or immediate reimbursement for travel,” Brown-Friday.
Perhaps most important, Brown-Friday said, is to also recruit a diverse team of researchers that reflects the community at large.
“This is not just for looks,” Brown-Friday said. “A diverse team may be able to share in the lived experiences of participants, therefore making the trial more meaningful to the participants and to the research team.”
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Brown-Friday J. Improving diversity in clinical trials. Presented at: American Diabetes Association Scientific Sessions; June 23-26, 2023; San Diego.
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