March 9, 2022
National Institute on Aging (NIA)
This Request for Information (RFI) invites comments and suggestions for the National Institute on Aging (NIA) to consider as it explores strategies relevant to, challenges inherent in, and the potential benefits of capacity-building for community-based research networks, with the goal of engaging a wider, more diverse group of participants in Alzheimer’s disease (AD) and AD-related dementias (ADRD) clinical trials. Specifically, NIA seeks insights that will enable us to enhance sustainable engagement with a wide variety of participants, including people from underserved groups, which includes rural communities, people of various races and ethnicities, minority health and health disparity groups, and older people of diverse physical and neurological abilities, in AD/ADRD clinical trials. NIA solicits information on both the current capacity, and the additional resources needed, to leverage, augment, and/or create new configurations of community-based research network(s) to engage in the conduct of AD/ADRD clinical trials.
For the purpose of this RFI, a community-based research network is defined broadly as a multi-site network of healthcare providers and practitioners that extends beyond the confines of large academic medical centers and whose members can support and/or conduct AD/ADRD clinical trials. While there is not a singular definition of a community-based research network, there are numerous examples that NIA uses as context for developing an understanding of current models and capacity. Examples include, but are not limited to, the following:
NIA, one of the 27 Institutes and Centers of the National Institutes of Health (NIH), leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. NIA is the primary federal agency supporting and conducting AD research. NIA oversees a comprehensive portfolio of AD/ADRD clinical research designed to discover prevention and intervention strategies, care interventions, as well as diagnostic biomarker development and validation, with the goal of improving the lives of people living with dementia, their caregivers, and their communities. Following the enactment of the 2011 National Alzheimer’s Project Act (NAPA), and the subsequent increased investment in AD/ADRD research funding, NIA’s AD/ADRD research clinical portfolio has grown substantially; NIA is currently supporting more than 365 active AD/ADRD clinical trials. NIA has a robust infrastructure in its networks and centers that support many of the clinical trials, including many in large academic medical centers such as the Alzheimer's Disease Research Centers, Alzheimer’s Clinical Trials Consortium, Claude D. Pepper Older Americans Independence Centers (OAICs), NIA’s Impact Collaboratory, and the Edward R. Roybal Centers for Translational Research in the Behavioral and Social Sciences of Aging.
NIA recognizes that inclusion of research participants who are representative of the diverse American population is crucial to addressing health disparities, understanding the etiology of AD/ADRD across multiple populations within various environments, and improving the generalizability of research results. Moreover, having diverse participants in clinical trials enhances the research community's understanding of the full breadth of the safety and efficacy of a potential drug, or prevention strategy, and community/cultural relevance critical to effective care and caregiving. To help the research community engage participants from a wider range of racial, ethnic, regional, and cultural backgrounds, NIA released the National Strategy for Recruitment and Participation in AD/ADRD Clinical Research and its companion, the Alzheimer’s Disease and Related Dementias Clinical studies Recruitment Planning Guide.
This RFI seeks to gather insights on strategies needed to engage, and challenges hindering engagement with, research partners, such as community-based clinicians, community-based stakeholders, and community-based research networks. Their participation in clinical trials can have multiple benefits, including, but not limited to: increasing the number of clinicians who participate in the research enterprise; expanding access to the number of potential participants for AD/ADRD research clinical trials; increasing the geographic, racial, ethnic, and regional diversity of AD/ADRD research clinical trial participants; and providing the unique perspectives of community-based clinicians, which can improve clinical trial design and potentially improve the translatability of research findings to real-world clinical care. [i] [ii] For illustrative purposes, a sampling of NIA-sponsored projects which are currently pursuing various strategies of community-based engagement are included below.
Request for Information
This RFI seeks input on the potential value and inherent challenges related to various design configurations of community-based research networks which could be engaged to support the full range of AD/ADRD clinical trials in scalable, sustainable, and/or adaptable fashion. NIA seeks insights from multiple perspectives to obtain a comprehensive understanding of the requirements needed, and successful strategies employed, to engage historically underrepresented communities who are disproportionately affected by AD/ADRD and are underrepresented in clinical trial participation.
NIA welcomes responses from all interested parties, including, but not limited to, the following anticipated respondents:
Topics of Interest
To help guide feedback, respondents may address one or more of the topics of interest below. Respondents are encouraged to provide detailed descriptions, examples, publications, and additional information regarding context that will help clarify their response(s). NIA would also appreciate feedback that addresses additional areas of interest not covered by these topics but is relevant to the development of outreach efforts to increase clinical research engagement and participation within community settings. Organizations are welcome to submit a single response reflective of the views of the organization.
How to Submit a Response
All comments must be submitted electronically on the submission website.
Responses must be received by 11:59:59 pm (ET) on 04/09/2022.
Responses to this RFI are voluntary and may be submitted anonymously. You may voluntarily include your name and contact information with your response. If you choose to provide NIH with this information, NIH will not share your name and contact information outside of NIH unless required by law.
Other than your name and contact information, please do not include any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government will use the information submitted in response to this RFI at its discretion. Other than your name and contact information, the Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.
We look forward to your input and hope that you will share this RFI opportunity with your colleagues.
Examples of current NIA-sponsored programs seeking to increase community engagement
NIH is investing in a wide range of activities that facilitate community engagement and the inclusivity and diversity of participants. Examples include, but are not limited to, the following:
[i] National Cancer Institute Community Oncology Research Program (NCORP) (NCI Community Oncology Research Program (NCORP) (cancer.gov))
[ii] Unger JM,Hershman DL,Till C, et al. “When offered to participate”: a systematic review and meta-analysis of patient agreement to participate in cancer clinical trials. J Natl Cancer Inst 2021;113:244-257.
Rebecca A. Roper, MS, MPH
National Institute on Aging (NIA)
Division of Extramural Activities