TABLE 2.

Recommendations to enhance and secure Latino AD/ADRD clinical trial participation based on the Micro‐Meso‐Macro Framework for Diversifying AD/ADRD Trial Recruitment.

	Recommendation	Summary	Framework dimension
1	Make binding all diversity plans at the Food and Drug Administration (FDA) for AD/ADRD clinical trials	The FDA should make it binding that all clinical trials incorporate diversity plans seeking approval to commercialize treatments. Proactive strategies to incorporate public input from diverse Latino stakeholders should be fomented on future drafts of guidance documents related to AD/ADRD clinical trials.	Macro
2	The National Institutes of Health (NIH) to continue to require robust initiatives and diversity plans for all AD/ADRD clinical trials.	The NIH and other sponsors should favor funding clinical trials with robust diversity plans. Trial sites should report on the racial/ethnic composition of their catchment area. Sites should be required to have protocols and bilingual/bicultural personnel in place to recruit Latino participants if they comprise more than 20% of the catchment area.	Macro
3	Issue a call to pharma partners (PP) and clinical research organizations (CRO) to address structural factors that inhibit Latino representation in AD/ADRD clinical trials.	The need for collaboration across all parties is paramount. Federal and state policies that incentivize PP and CRO should be developed with the goal of reducing disparities in research participation. Community‐level strategies (education, screening, preventative care, patient navigation, etc.), should be financed at robust levels, and staffing patterns reviewed to reflect Latino representation at all levels of the organization.	Macro, meso
4	Honor Latino representation throughout the design of the clinical trial	Researchers should provide evidence of study designs that are co‐designed with community partners, and respectful of Latino priorities, values, and inclusionary practices. Novel incentives should be considered and study partner criteria should be modified. Principal investigators (PIs) should consider Latino scientists in PI‐succession plans.	Meso, micro
5	Shift to—and embed operations—within Latino communities and settings	Researchers should identify ways to conduct trial visits in Latino communities and settings. Embed trial work in communities, and hire research personnel from these communities.	Meso, micro
6	Focus on Latino participants’ healthcare needs and preferences for information	Researchers should offer follow‐up healthcare services to address unmet healthcare needs and preferences of Latino participants.	Macro, meso, micro
7	Creatively address limited literacy in English and Spanish	Sponsors should support initiatives to recruit Latino participants with limited English‐ and/or Spanish‐language literacy. Researchers should stratify participants by literacy level and offer incentives to address literacy issues.	Macro, meso, micro
8	Dissemination of findings should require information on sample representativeness	Organizers of scientific conferences and journal editorial boards should require transparency of sample demographic data and encourage studies on subgroup differences, including race and ethnicity, among others.	Macro
9	Expand research initiatives to include diverse cohorts and etiologies related to cognitive health based on what matters most to the Latino community	Cross‐institutional/sectorial funding should expand our etiologic understanding of factors linked with cognitive decline and resilience among Latino people from an intersectional perspective. Trials should promote research priorities on issues that matter most to Latino participants.	Macro, meso, micro
10	Support national legislation promoting trial participation of underrepresented groups	All actors in this space should support legislative policies advancing the science of inclusion in research and clinical trials and provide technical assistance to enhance diversity (eg, the Equity in Neuroscience and Alzheimer's Clinical Trials Act)	Macro, meso