Background: Eligibility criteria are an integral component of clinical trials, ensuring participant safety and reducing factors that may confound results. Research suggests that unnecessarily restrictive exclusion criteria may disphroportionately exclude African Americans (AA) and Hispanics/Latinos (H/L), reduce generalizability, and prevent timely enrollment. This may be of particular concern for Alzheimer's and related dementias (AD/ADRD), as AA and H/L are at greater risk than non-Hispanic Whites for AD/ADRD yet underrepresented in clinical trials (CT). This abstract analyzes exclusion criteria proposed within active National Institute on Aging (NIA)-funded AD/ADRD CTs (N=235) to document the most widely used criteria and to analyze the potential impact on AA and H/L CT participation. Method:CT exclusion criteria and study design were obtained from NIA grant folders and ClinicalTrials.gov. A codebook was developed using a sample of CTs to identify key exclusion categories (N=47 categories; intercoder reliability=92%) and used to code
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.
Background: Though Hispanics/Latinos (H/L) comprise 18% of the U.S. population and are 1.5 times at greater risk for Alzheimer's and related dementias (AD/ADRD) than non-Hispanic Whites, a median of only 2% of participants in NIH-funded AD/ADRD clinical trials are H/L. Reasons abound for this inequity; key documented impediments to enrollment of Latinos are too few researchers offering studies and limited materials that provide culturally and linguistically relevant information. This abstract presents findings from focus groups conducted by the National Institute on Aging (NIA) to identify salient, culturally appropriate message concepts that raise awareness, address barriers, and motivate H/L to consider participation in AD/ADRD studies.Method: Twelve remote focus groups (N=72) were conducted among two H/L audiences: 1) those at risk for AD/ADRD; and 2) those caring for a family member or friend with AD/ADRD. Messages were designed to motivate H/L to learn more about AD/ADRD clinical studies. Sessions explored participants' knowledge, attitudes, and beliefs regarding AD/ADRD and clinical studies. Participants reviewed and provided feedback on messaging designed to motivate them to seek more information about AD/ADRD clinical studies.Result: Message concepts that resonated strongly were those that 1) framed clinical studies as one step to finding a cure for AD/ADRD and 2) connected participation with helping their family members' future health. Concepts were more acceptable if they represented multi-generational families, emphasized the importance of family support, and promoted diversity and inclusivity (showing a diversity of age, gender, skin tone). Participants requested that concepts offered more opportunities to learn about Alzheimer's and local clinical studies. Trusted concepts are those that clearly identified the document's source and avoided the terms "trial" and "dementia," as both had negative connotations in the Spanish language. Conclusion:The data from these focus groups improve our understanding of message concepts that motivate H/L to consider participating in AD/ADRD clinical research.
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