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Written by Jean Albanese
Published on Thursday, September 29, 2022
In April, the FDA laid out new requirements for diversity recruitment plans in clinical trials for any new drugs or devices requiring the agency’s approval.
But one Upstate doctor and a newly appointed Community Research Liaison had already made it their mission to reach out into the Syracuse community to engage patients of different ages, ethnic backgrounds, and genders to encourage them to participate in clinical trials.
And they are doing it by building relationships, listening to input, and establishing trust.
With a $372,000 grant from the National Institute of Aging, Sharon Brangman, MD, chair of geriatrics at Upstate and the director of the Upstate Center for Excellence for Alzheimer’s Disease, and Kathy Royal, MA, Upstate’s new community research liaison, are working to improve diversity of all kinds in research across the country on aging, cognitive loss, Alzheimer’s disease, and dementia.
Royal came to Upstate in July 2021 with deep community connections already in place.
A certified life coach, with master’s degree in management, Royal brings with her many years of experience in the human services industry, including work as a life coach for the Women’s Opportunity Center, as a youth educator and advocate for the Salvation Army, and an HIV advocate for the Center for Community Alternatives.
The initiative has already yielded success. Thanks to Royal’s efforts, a recent study at Cornell University received 35 referrals, all of whom were African American. Thirteen were eligible and participated. Before Royal got involved, the project had no African American representation for the first six months.
Royal is currently recruiting for a local diabetes study and has helped recruit for studies at Stanford, Emory and Northwestern universities.
Historically, medical research has been done by white men and only included young, healthy white men which doesn’t accurately represent the geriatric or minority populations she is working to serve.
For example, Brangman said there is not enough diversity for trials for Alzheimer’s drugs. She points to a recent drug that got approved to remove amyloid plaques in the brain and the international trial had only 19 African Americans, and a small group of Asians and Latinos.
“That is completely unacceptable when Alzheimer’s disease has a significant impact in African-Americans and Latinos, but they are not represented in the clinical trials,” Brangman said.
As part of the grant, Brangman and Royal participate in a Community Research Recruitment Accelerator on Aging (CRRA-Aging). These meetings of local people including institutional researchers, community organizers, caregivers, and older adults from the community at-large started in October 2021.
No longer is it appropriate for researchers to pop into a community, get what they need and get out. Instead, Brangman and Royal are taking the “coffee and a bench” approach of sitting down, listening to concerns, understanding obstacles, answering questions, and involving the community in what topics are studied.
It all boils down to building trust especially in communities of color, which Royal said takes time after decades and even centuries of mistrust due to neglect and mistreatment by the medical community.
“My job is to go into the black and brown community—my community—to educate and motivate community members about the importance of participating in research and give them a little history on research,” Royal said. “What it was like then and what it is like now and to encourage them to get involved because we are needed to make sure medications are made using our input.”
Brangman said pharmaceutical companies and researchers are beginning to understand this, and she points to the new FDA guidelines as bringing federal support to her efforts.
David Amberg, PhD, Upstate’s vice president for research, said lack of diversity has led to the approval of drugs and medical interventions with little knowledge of their effectiveness or side effects in black and brown communities.
“Sharon Brangman has been working with Mt. Sinai on an NIH-funded project to develop a community-based approach to solve this problem,” he said. “Thus far their success has been remarkable in achieving 25 percent African American participation in several trials.
"As a consequence, Dr. Brangman and her team have been receiving great interest from large pharma companies to partner and scale their approach. This has become all the more important as the FDA recently released mandates that all clinical trials will need to have an effective diversity plan to receive FDA approval.”
If you are interested in joining a trial or getting more information for trial recruitment, call Royal at (315) 464-3285 or email her at email@example.com.
Caption: Community Research Liaison Kathy Royal, MA, and Sharon Brangman, MD.