NOT-AG-23-080: Notice of Intent to Publish a Funding Opportunity Announcement for Deriving Common Data Elements from Real-World Data for Alzheimers Disease (AD) and AD-Related Dementias (ADRD) (U24 Clinical Trial Not Allowed)

Notice of Intent to Publish a Funding Opportunity Announcement for Deriving Common Data Elements from Real-World Data for Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) (U24 Clinical Trial Not Allowed)

Notice Number:

NOT-AG-23-080

Key Dates

Release Date:

February 02, 2024

Estimated Publication Date of Notice of Funding Opportunity :

March 29, 2024

First Estimated Application Due Date:

June 14, 2024

Earliest Estimated Award Date:

April 14, 2025

Earliest Estimated Start Date:

April 14, 2025

Related Announcements

March 13, 2023 - Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) Real-World Data Platform (U54 Clinical Trial Optional). See NOFO RFA-AG-24-009.

Issued by

National Institute on Aging (NIA)

Purpose

NIA intends to publish a Notice of Funding Opportunity (NOFO) soliciting applications that aim to develop Common Data Elements (CDEs) for Alzheimer’s disease (AD) and AD-Related Dementias (ADRD) using Real-World Data (RWD) from electronic health records and Centers for Medicare & Medicaid Services (CMS) claims.

The CDEs will foster data harmonization and interoperability among data systems that involve disparate and unaligned RWD. By reducing the efforts required for data harmonization in using RWD for cross-sectional and longitudinal analysis, the NOFO may enable researchers to utilize RWD more efficiently and produce real-world evidence in a faster manner.

The NOFO is expected to be published in March 2024 with an expected application due date in June 2024. Please note that these time frames are simply estimations, and they may change.

The NOFO is expected to utilize the Resource-Related Research Projects – Cooperative Agreements (U24) activity code.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

Additional details regarding the planned NOFO are below.

Research Initiative Details

RWD originate from everyday health care interactions, making it a crucial resource for various medical research and applications. Some examples of RWD include electronic health records, claims and billing data, registry data, and data collected from digital health technologies. However, RWD relevant to people living with AD/ADRD are often not aligned or harmonized. CDEs are defined fields and structures that enable interoperability among data systems and have the potential to harmonize RWD to assist AD/ADRD research. Reducing the efforts required for data harmonization in using RWD for analysis may enable researchers to utilize RWD faster and more efficiently.

To facilitate the use of RWD for AD/ADRD research, the NOFO is expected to include a cooperative agreement. Under the agreement, researchers will standardize vocabulary and identify, develop, and test longitudinal CDEs by using EHRs and the CMS Chronic Conditions Data Warehouse (CCW) data. Additionally, researchers would be required to collaborate with the grant recipient of RFA-AG-24-009. 

The NOFO is expected to have the following objectives:

Identify Research Questions and Use Cases:
- Collaborate with stakeholders (e.g., health and social care professionals, people living with dementia, caregivers, policymakers, EHR vendors) and researchers to identify research questions and use cases that can be addressed by CDEs
- Align selected use cases with AD/ADRD research milestones 1.J, 3.B, 11.B, and 13.Q and integrate various RWD sources to achieve comprehensive outcomes for aging populations
- Evaluate the feasibility, availability of data, and acceptability within the research community for each use case
Develop CDEs Encompassing Seven Domains:
- Utilize insights from a technical expert panel meeting to create CDEs encompassing the following seven domains:
  1. Patient and caregiver demographic information
  2. Disease characterization, including AD/ADRD diagnosis and multiple chronic conditions
  3. Health assessment (e.g., Activities of Daily Living (ADL), Instrumental ADL, cognitive function, etc.)
  4. Biomarkers, genetics, and genomics relevant to AD/ADRD
  5. Treatment for all conditions
  6. Patient and caregiver health outcomes
  7. Social determinants of health (e.g., financial, education, and living arrangements), but not environmental data (e.g., weather data, pollutant data)
Create Applicable Longitudinal Files and CDEs:
- Utilize CMS CCW files to establish AD/ADRD research longitudinal files
- Develop CDEs that consider evolving coding schemes over time to ensure accuracy and relevance
Evaluate and Refine Developed CDEs:
- Rigorously test the developed CDEs and iteratively refine them based on findings and updates in coding schemes
- Ensure compatibility with various NIA RWD infrastructures, including the RWD platform established under RFA-AG-24-009 and other systems set up by NIA-funded researchers. A Program Official and Project Scientist(s) from the National Institutes of Health will facilitate collaboration with the RWD platform established under RFA-AG-24-009

The NOFO is expected to require the following activities:

Administration: Organize and lead a governance structure to facilitate research, administration, innovation, and dissemination activities
Innovation: Select use cases, develop guidance for CDE collection and utilization, use advanced data analytics for longitudinal data harmonization, and manage a research study program to encourage adoption of developed CDEs
Dissemination: Disseminate project-supported products via a comprehensive website, annual national CDE User meetings, research briefs, blogs, and other means

Funding Information

Estimated Total Funding

NIA intends to commit $4,000,000 in fiscal year (FY) 2025 in total costs.

Expected Number of Awards

Estimated Award Ceiling

For FY2025, the budget for direct costs may not exceed $2,500,000 per year.

For FY2026-2030, the budget for direct costs may not exceed $3,500,000 per year.

Application budgets need to reflect the actual needs of the proposed project.

Primary Assistance Listing Number(s)

TBD

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Indian/Native American Tribal Government (Other than Federally Recognized)

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Chun-Ju (Janey) Hsiao, PhD, MHS
Division of Behavioral and Social Research
National Institute on Aging (NIA)
Email: janey.hsiao@nih.gov

Nadezda Radoja, PhD
Division of Neuroscience
National Institute on Aging (NIA)
Email: nadezda.radoja@nih.gov

Marcel Salive, MD, MPH
Division of Geriatrics and Clinical Gerontology
National Institute on Aging (NIA)
Email: marcel.salive@nih.gov