The Urgent Need for Increased and Diverse Participation in Studies
The increased investment in Alzheimer’s and related dementias research has enabled the scientific community to ask and pursue broad clinical questions. With the increased number of treatment, prevention, and care studies comes the urgent need to recruit and enroll dozens to thousands of participants. Alzheimer’s and related dementias research studies especially need participants who better represent the diversity of the U.S. population. To address the imperative for diverse participation in clinical studies, NIH is investing in a range of methods, resources, and research to help investigators with recruitment and retention:
- NIA, in collaboration with the Alzheimer’s Association, sought expertise and insights from stakeholders representing government, nonprofit organizations, private industry, and academic institutions, as well as individuals with dementia, their caregivers, and active study participants. Released in late 2018, Together We Make the Difference: National Strategy for Recruitment and Participation in Alzheimer’s and Related Dementias Clinical Research is a compilation of the information and guidance obtained, and outlines steps needed, to address the challenges and opportunities for recruitment. NIA plans to convene a meeting of key stakeholders, both those who participated in the strategy’s development and those engaged in implementation efforts, to address several key topics, including:
- Reporting on progress made thus far for each goal, both from NIA and its grantee researchers across the nation
- Identifying remaining challenges to the strategy’s implementation
- Setting priority areas and goals for the next three years to build on progress, address the gaps identified, and disseminate lessons learned to date
- Ensuring that recruitment strategies support ethical and inclusive approaches that address the broad spectrum of people with dementia.
- To provide researchers with practical and proactive approaches for engaging a wider, more diverse range of research participants, NIH is investing in a vast range of supportive resources, including the Why I Participate in Alzheimer’s Research video series, developed and released in 2019. This series is designed to motivate individuals to volunteer for research by enabling them to hear members of underrepresented communities describe their personal stories of why they chose to enroll in an Alzheimer’s study.
- NIA continues to develop outreach and education materials that take into consideration a range of cultural and language-specific communication needs and preferences:
- In 2019, NIA conducted formative research to develop a set of materials tailored to African American audiences, including videos, print ads, posters, social media, and other multimedia messages.
- In 2020, NIA is using a similar approach to develop a set of materials, tailored to Latinos, in both English and Spanish. Formative research and communication activities to enhance outreach to other underrepresented populations will be conducted in subsequent years.
- NIA is currently developing a web-based communication tool that will enable health care professionals in the community to easily produce a package of tailored materials and strategies that can be branded locally to increase participant recruitment for clinical studies. This web-based tool will allow the research community to access, adapt, and personalize the materials that NIA has developed for underrepresented communities.
- As part of the implementation of the national strategy, NIA’s website features Alzheimer’s & Dementia Outreach, Recruitment & Engagement Resources (ADORE), an online, searchable database of materials for clinical trials recruitment and retention. The ADORE platform is designed to facilitate the sharing of materials on topics related to engagement, recruitment, and retention of participants in clinical studies. Resources in ADORE, such as the Why I Participate in Alzheimer’s Research videos described above, represent some of the materials and activities developed by NIA- supported Alzheimer’s disease research centers and other grantees. The database also includes relevant resources from other organizations, as well as published research articles.
Tracking the enrollment and recruitment performance of NIH-supported clinical studies for Alzheimer’s and related dementias is also a priority. To this end, NIH is investing in the expansion of its clinical trial data infrastructure to more seamlessly track enrollment in NIH-funded clinical studies. This effort will also proactively support recruitment needs across the breadth and scope of the research portfolio.
The NIH-funded Alzheimer’s Clinical Trials Consortium (ACTC), a clinical trials infrastructure to accelerate and expand studies for therapies in Alzheimer’s and related dementias, also is investing in methods and strategies to enhance recruitment of racial and ethnic minority participants. ACTC relies on community engagement using an innovative hub-and-spoke model to create a core of community-based minority and patient advocates who work closely with the recruitment units at ACTC sites. These advocates serve as liaisons between the community and the ACTC sites, and they communicate the concerns and perspectives of potential and enrolled study participants.
For a more in-depth look at the research implementation milestones in this area, including progress and accomplishments, visit www.nia.nih.gov/research/milestones/trial-innovation.