Toward a Framework to Improve Diversity and Inclusion in Clinical Trials Proceedings of a Workshop (2025) / Chapter Skim
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4 Clinical Trial Site Enablement
4 Clinical Trial Site Enablement
Pages 31-40
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From page 31... ...
(Flowers, Rutter) • Community health centers can be ideal partners in clinical trials because they serve populations most frequently excluded from trials and, in many cases, are already engaged or are interested in clinical trials, but their strained workforce and trust issues based on negative experiences with the clinical research enterprise remain barriers to participation.
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From page 32... ...
They are not intended to reflect a con sensus among workshop participants. Panelists considered practical ways to enable established and developing sites, including community-based practices, to increase capacity to conduct more equitable and representative clinical trials.
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From page 33... ...
Program supports activities focused on translating research into practice,1 including those aimed at addressing health disparities, increasing access of underrepresented populations to clinical trials, and training and retention of a diverse clinical trials workforce. The CTSA network includes partnerships between major academic institutions, Federally Qualified Health Centers (FQHCs)
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people receive primary care services at one of nearly 1,500 nonprofit community health centers, according to Amy Flowers, director of policy research at the National Association of Community Health Centers (NACHC)
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VALUING DIVERSE REPRESENTATION IN DEVICE TRIALS Megan Coylewright, an interventional cardiologist and vice chief of cardiology at Erlanger Health System, one of the largest public health hospitals in the country, shared her personal experience with running device clinical trials in diverse communities. She serves on the executive steering committee for 10 large randomized global trials for cardiac devices at Erlanger.
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From page 36... ...
Beyond Walls program, which has treated 30,000 patients, grew out of the advanced care at home programs initiated during the COVID-19 pandemic.5 It provides patients with a tablet that facilitates around-the-clock support from a physician and nurse. A llied health teams provide care in the home, which presents an opportunity to train a new field of medical researchers who specialize in home care and clinical trials.
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From page 37... ...
posts, and community-based registries of individuals who are interested in clinical trial participation should the opportunity arise. Willman concluded by saying the goal is "meeting people where they are," which can be assisted by digital technology to enable "in-facility, home-based, and virtual digital care to support a patient… with any illness on their entire disease journey." FOSTERING COMMUNITY READINESS TO CONDUCT TRIALS AT SCALE Kristen Nwanyanwu, a retinal surgeon and associate professor of ophthalmology and visual science at Yale University, discussed the Yale Equitable Breakthroughs in Medicine Development (EQBMED)
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From page 38... ...
For example, Mayo Clinic maintains virtual portals in the VFW posts in Jacksonville, Florida, and holds meetings there. At FQHCs in Arizona, Mayo Clinic has started the Demand Access program to bring culturally appropriate clinical trial navigators and staff to the community.
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From page 39... ...
Nwanyanwu said it is important to assess and acknowledge how much increasing inclusivity and representation in trials might cost. SUSTAINABLE PARTNERSHIPS Cherié Butts, medical director of the therapeutic developments unit at Biogen and member of the Forum on Drug Discovery, Development, and Translation, asked how best to enable sites to manage increased interest in clinical trials without becoming overwhelmed and turning people away, and, conversely, how community engagement in clinical research can be sustained when some must be turned away due to excess interest.
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From page 40... ...
She suggested looking to how the Patient-Centered Outcomes Research Institute funds small studies by community-based organizations.10 Moses added that small organizations often start community programs and services with seed funding but then don't not have sufficient data to secure additional funding to sustain them. She further observed that this lack of sustainability feeds the lack of trust communities have in outside organizations that approach them.
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