Analysis of recruitment planning for under‐represented participants in NIA‐funded Alzheimer’s disease and Alzheimer’s disease related dementias clinical trials

Abstract

Background Inclusion of underserved participants is mandated by the National Institutes of Health (NIH), yet they remain under‐represented in NIH research, including Alzheimer’s and Related Dementias (AD/ADRD) clinical trials. Diverse representation is critical in AD/ADRD trials as African Americans (AA) and Hispanics/Latinos (H/L) are disproportionately affected by the disease. Research indicates that a priori recruitment planning is critical to successful recruitment into trials. This abstract analyzes the planned inclusion enrollment reports (IERs) and recruitment strategies described in grant applications for active National Institute on Aging (NIA)‐funded AD/ADRD clinical trials (N=271) Method This analysis used two methods: 1) documented the planned IERs for each NIA‐funded AD/ADRD clinical trial (active as of 10/16/2020); 2) conducted content analysis documenting: a) justification for IER, b) presence of a plan (yes/no), c) key enrollment strategies proposed (overall and for under‐represented populations), and d) quality of proposed recruitment planning (intercoder reliabilities: 80‐90%). Result Across the trials, median percent of total enrollment goal by IER categories were: Non‐Hispanic (91%) vs. Hispanic (9%); White (74%), AA (16%), Asian (4%), Other Races (2%). The top reason (62%) justifying trials’ IERs was “proportions represents trial site demographics.” Only 5% reported “proportions represent disease studied.” Most trials (91%) provided recruitment plans; however, 55% included no strategies specific to recruiting under‐represented populations. The majority (52%) of plans were rated medium quality (2‐3 strategies); the remaining were equally split between low and high quality (24% each). A median of 2 recruitment strategies were listed per trial; top strategies were: 1) traditional advertisements, 2) underserved‐focused community outreach, and 3) provider referrals. Additional analyses will be reported by intervention type, trial phase, and site type. Conclusion Our findings show inclusion planning for active NIA AD/ADRD clinical trials is heavily weighted towards non‐Hispanic Whites. Even if trials meet their IER goals, they will be under‐enrolling H/L, Asians, and Other Races as compared to the US Census data (2019). Most trials have recruitment plans, though not focusing on strategies targeted at recruiting those under‐represented. NIA should consider developing more robust guidelines to ensure grant applications have targeted, achievable, evidence‐based minority recruitment goals and plans set a priori.

A call to address structural barriers to Hispanic/Latino representation in clinical trials on Alzheimer's disease and related dementias: A micro‐meso‐macro perspective

“…One barrier to Latino representation emanates from study review and approval criteria that perpetuate failed accruals of recruitment targets, namely recruitment and retention of Latino participants. As discussed above, sentinels of flawed trial design include lack of sufficient bilingual/bicultural personnel (even when the catchment area has mostly Latino residents), 47 and unclear and underfunded recruitment and retention plans/budgets 48 . Thus, this structural barrier addresses how research funders and regulatory entities approve initial funding of AD/ADRD trials with thin recruitment and retention plans/budgets, and subsequent trial funding even though awardees’ annual reports indicate failures in meeting planned enrollment goals related to Latino participation.…”