At the Alzheimer’s Association International Conference® (AAIC®) 2021, in Denver and virtually, researchers shared new evidence-based insights into why people from communities of color do and do not choose to participate in clinical trials.
| DENVER, July 29, 2021 /PRNewswire/ -- A significant hurdle in developing therapeutics and care models for Alzheimer’s disease that work for people of all ethnic and racial backgrounds is the recruitment and retention of traditionally underrepresented groups in clinical trials. At the Alzheimer’s Association International Conference® (AAIC®) 2021, in Denver and virtually, researchers shared new evidence-based insights into why people from communities of color do and do not choose to participate in clinical trials.
Also at AAIC 2021, the National Institute on Aging (NIA), part of the U.S. National Institutes of Health, launched a new online tool, Outreach Pro, to help researchers and clinicians increase awareness and participation in clinical trials on Alzheimer’s disease and other dementias, especially among traditionally underrepresented communities. “There is a well-recognized need for diversity in clinical trial populations to ensure diagnostics and treatments are safe and effective for everyone,” said Carl V. Hill, MPH, Ph.D., Alzheimer’s Association chief diversity, equity and inclusion officer. “It’s imperative that the Alzheimer’s community is aware of the impact of historical racism, and also the current racial discrimination in health care that presents obstacles for inclusive participation in Alzheimer’s trials. And, just as important, it is critical that we evaluate strategies that have been shown to be effective when recruiting historically underrepresented individuals and communities in these vital Alzheimer’s research studies.” Other key findings reported first at AAIC 2021 include:
The Alzheimer’s Association is leading two major clinical trials with a strong focus on diverse participation. The New IDEAS study is recruiting 2,000 Latinos and 2,000 African Americans to investigate the impact of a brain amyloid PET scan on clinical care outcomes, including diagnosis and treatment. The U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) study is a two-year clinical trial studying the effects of multi-component lifestyle interventions on risk of cognitive decline in a diverse population in the U.S. NIA Launches Alzheimer’s Research Recruiting Materials for Under-Represented Communities Using NIA’s Outreach Pro, researchers and clinicians can make outreach materials from templates designed to:
Each template can then be tailored using a central library of messages, headlines, photos and text that have been extensively tested with individuals, including those representing diverse and underserved populations. The development of Outreach Pro is an integral part of NIA’s efforts to implement the National Strategy for Recruitment and Participation in Alzheimer’s and Related Dementias Clinical Research. Released in 2018, the national strategy was developed with facilitation by the Alzheimer’s Association, with the goal of engaging broad segments of the public in Alzheimer’s and dementia research, with a particular focus on underrepresented communities. “It is critical that clinical trials have appropriate representation to ensure that we have a complete understanding of how well different therapies or approaches to dementia care work in different populations,” said Holly Massett, PhD, Senior Advisor on Clinical Research Recruitment and Engagement at NIA, who oversees the implementation of the national strategy. “Outreach Pro was designed to provide well-tested and culturally appropriate outreach materials that resonate with diverse populations and encourage them to participate in clinical trials.” Outreach Pro’s current library of content includes materials designed specifically for African American and Hispanic/Latino populations and is available in English and Spanish. Plans are underway to add materials developed for Asian Americans and Pacific Islanders in multiple languages by Fall 2021, and materials for American Indian and Alaska Native communities to be developed and added in 2022. People More Likely to Participate Clinical Trials if Invited By Someone of the Same Race Factors most highly associated with willingness to volunteer for a study in the full group were (1) Invited to Participate (85%), (2) Research Goal (83%), and (3) Family Member with Disease (74%). Significant differences were observed between the White and minority groups. Notably, African American, Latino and American Indian respondents are significantly more likely to volunteer for a research study if asked by a person of the same race, and they are more concerned than Whites about disruption of work and family responsibilities, availability of transportation, and childcare. “We identified opportunities for tailored messaging designed to increase awareness of the value of Alzheimer’s research participation,” said Farrar Edwards. “As we get better at recruiting diverse populations, it will increase the urgency to get the conduct of trials right.” Are Common Exclusion Criteria in Alzheimer’s Clinical Trials Keeping out Underrepresented Groups? Alexandra Mitchell, Clinical Research Coordinator at NIA, Holly Massett, Ph.D., NIA Senior Advisor on Clinical Research Recruitment and Engagement, and colleagues conducted a content analysis of 235 active NIA-funded Alzheimer’s and dementia clinical trials to identify the most widely used criteria and their potential to disproportionately exclude African Americans and Hispanics from the research. They identified 2,761 exclusion criteria and grouped them into 56 categories. On average, each trial had 11.75 exclusion criteria, with drug trials having the highest (18.14 per trial). Not surprisingly, “dementia/cognitive impairment” was the most common category (identified in 49% of trials). However, the next three most common categories included medical, neurological and psychiatric-related criteria that were classified as “broadly defined” such that they could introduce an unintentional level of subjectivity by investigators when determining participant eligibility. Additionally, the researchers found that 142 trials (60%) had at least one exclusion category that could disproportionately affect African American or Hispanic populations. “This analysis is helping us ask an important question: Can we strengthen our criteria for clinical trials to maximize the number of eligible people from diverse and under-represented communities?” said Mitchell. “We hope the Alzheimer’s community will take a closer look and can mimic the success in the oncology field where a concerted effort resulted in reworded, more equitable exclusion criteria.” About the Alzheimer’s Association International Conference (AAIC) About the Alzheimer’s Association
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