Case Study: New Site Development Program Aimed at Improving Access and Enrollment in Clinical Trials for Traditionally Underrepresented Populations (TUP)

Abstract

AbstractBackgroundIncreased awareness and access to clinical trials is essential for recruitment of traditionally Underrepresented Populations (TUPs) into Alzheimer’s disease clinical trials. Identifying trusted physicians in diverse communities and helping build new Alzheimer’s research sites is an effective approach to materially increasing UP participation in clinical research. Global Alzheimer’s Platform (GAP) partnered with two Primary Care Physicians in Rio Grande City, Texas to open a new Alzheimer’s research facility.MethodGAP identified the Rio Grande Valley area to open an Alzheimer’s disease trial site for multiple reasons: high prevalence (∼20%) of Alzheimer’s, significant (98%) Hispanic/Latino population, trusted community physicians with a large geriatric patient population, and lack of access to research opportunities. GAP worked with the physician(s) to develop a project plan to open the clinical trial site. Areas addressed included space, staff, supplies, subjects, and sponsors. Several obstacles to overcome included tracer availability, finances, raters, and training for a clinically sound, but research‐naïve team.ResultAfter 7 months of site development, El Faro Health & Therapeutics (El Faro) opened in November 2021. The site was approved for their first trial in January 2022. The site has completed feasibility or has initiated onboarding for up to 5 additional projects and intends to activate in up to 3 more trials by Q2 2022. In their first three months, the site has completed ∼85 memory screens and reviewed more than 200 charts to begin developing a potential participant database. El Faro successfully leveraged their strong community relationships gaining media attention from over 10 media sources. Additional updates on referrals, prescreens, screens and randomizations will be provided at the conference.ConclusionMembers of the Hispanic/Latino community are 1.5 times more likely to develop Alzheimer’s disease; however, they make up ∼1% of AD clinical trial participants. By establishing an AD research center in Rio Grande City, TX, barriers to participation are being removed, which will result in an increase in trial enrollment of UPs. The success of El Faro will demonstrate that true equity can be achieved in Alzheimer’s research with collaboration from local leaders in diverse communities.