Deriving Common Data Elements from Real-World Data for Alzheimers Disease (AD) and AD-Related Dementias (ADRD) (U24 Clinical Trial Not Allowed)

The National Institute on Aging (NIA) is seeking applications for the development of Common Data Elements (CDEs) for studies on Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) using Real-World Data (RWD). This initiative aims to harmonize and standardize data across NIA-funded research projects and Centers for Medicare & Medicaid Services (CMS) claims data. By creating consistent, interoperable datasets, the program seeks to improve the utility of RWD for longitudinal analysis and accelerate research progress on AD/ADRD prevention, treatment, and care. The funding opportunity will provide a cooperative agreement mechanism (U24) with a total budget of $4 million in fiscal year 2025 for one award. Direct costs for each of the five years may not exceed $3.75 million annually. Applications must propose activities that align with the development of CDEs in seven key domains: demographic data, disease characterization, health assessment, biomarkers/genetics, treatment, outcomes, and social determinants of health. Key goals include fostering collaboration, utilizing advanced technologies like AI and machine learning, and establishing tools and guidelines for harmonized data use. Eligible applicants include higher education institutions, nonprofits, for-profit entities, state and local governments, tribal organizations, and public housing authorities. Foreign organizations are not eligible, although foreign components may be included. Applicants must meet registration requirements with the System for Award Management (SAM), eRA Commons, and Grants.gov before submission. Organizations may submit multiple applications provided each is scientifically distinct. Applications will be evaluated based on their significance, approach, innovation, investigator qualifications, and institutional environment. Key review criteria include the feasibility of proposed milestones, the use of CMS data, and the inclusion of novel methodologies to achieve research objectives. The program mandates the creation of a public-facing website to share developed CDEs, harmonization tools, and data. Additionally, applicants must organize an annual user meeting, beginning virtually in the first year and transitioning to in-person in Bethesda, MD, thereafter. Substantial NIH involvement is anticipated throughout the project, including collaboration with researchers and guidance on project priorities. The cooperative agreement will also support external research studies through a national competition, with funds allocated for up to six projects annually starting in year two. Milestones must include timelines for CDE development, harmonized data release, and stakeholder engagement. Applications must comply with data-sharing policies and outline plans for FAIR (Findable, Accessible, Interoperable, and Reusable) principles. A detailed Data Management and Sharing Plan is required. Submission deadlines and detailed instructions are available in the funding opportunity announcement. Interested applicants are encouraged to submit a letter of intent by January 28, 2025, and complete applications by February 28, 2025, via Grants.gov. Awards are expected to begin in December 2025.