Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development (UG3/UH3 - Clinical Trial Optional)
National Institutes of Health (NIH)
Funding amounts are not limited but must reflect the actual needs of the proposed project.
The project duration can be up to 5 years, with the UG3 phase lasting 1-2 years and the UH3 phase lasting 3-4 years.
To support the development and validation of DHT derived biomarkers or COAs for remote monitoring in clinical trials.
To fill a defined unmet clinical endpoint for interventional clinical trials.
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Cancer Institute (NCI)
National Institute on Aging (NIA)
Patient advocacy organizations and communities involved in clinical trials.
Eligible organizations include higher education institutions, nonprofits, for-profit organizations, small businesses, local, state, and federal governments, and tribal governments.
Non-domestic (non-U.S.) entities are not eligible to apply.
Organizations must be based in the U.S. or its territories.
Non-domestic components of U.S. organizations are not eligible to apply.
Projects must develop and validate DHT derived assessments in three or more diseases or conditions.
Partnerships with patient advocacy organizations are required.
Application budgets are not limited but must reflect the actual needs of the proposed project.
Requests for $500,000 or more in direct costs in any year must contact NIH staff at least 6 weeks before submission.
Applications are due by June 22, 2026, at 5:00 PM local time of the applicant organization.
The earliest submission date is January 21, 2025.
Applicants may submit more than one application, provided each is scientifically distinct.
The NIH will not accept duplicate or overlapping applications under review at the same time.
Applications must follow the instructions in the Research Instructions in the How to Apply - Application Guide.
A community engagement plan and a timeline with milestones are required.
Applications will be evaluated based on scientific and technical merit, including significance, innovation, and approach.
Applications will undergo peer review and will be evaluated for completeness and compliance with application instructions.
Applications will compete for available funds based on scientific merit and relevance to program priorities.
Partnerships with patient advocacy organizations are mandatory.
Community engagement strategies must be included in the application.
Non-domestic entities are not eligible, limiting international collaboration.
Projects should align with NIH's mission and priorities in health research.
Strong community engagement and partnerships may enhance the competitiveness of applications.
Collaboration across multiple disease areas and with patient advocacy organizations is crucial.
Avoid submitting overlapping applications and ensure compliance with all application instructions.
Engage with NIH staff early in the application process, especially for large budget requests.
Highlight the innovative aspects of the proposed DHT derived assessments and their potential impact on clinical trials.