Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development (UG3/UH3 - Clinical Trial Optional)
Develop digital health technology-based biomarkers and outcomes for remote monitoring in clinical trials across multiple diseases, promoting standardization and collaboration with patient advocacy groups.
Funder: National Institutes of Health
Due Dates: June 20, 2025 (New/Renewal/Resubmission/Revision) | February 20, 2026 (New/Renewal/Resubmission/Revision) | June 22, 2026 (New/Renewal/Resubmission/Revision)
Funding Amounts: No budget limit; UG3 phase: 1–2 years, UH3 phase: 3–4 years, max 5 years total; actual budget must reflect project needs.
Summary: Supports development and validation of digital health technology-derived biomarkers and outcome assessments for remote monitoring as clinical trial endpoints across at least three diseases, requiring collaboration with patient advocacy organizations.
Key Information: Applicants must include at least three diseases/conditions and partner with non-profit patient advocacy groups; contact NIH if requesting ≥$500,000 direct costs/year.
Description
This NIH opportunity funds the rigorous development and validation of digital health technology (DHT)-derived biomarkers and clinical outcome assessments (COAs) for remote monitoring, intended for use as primary or secondary endpoints in interventional clinical trials. The program aims to improve clinical impact, increase statistical feasibility, and promote standardization by requiring applicants to develop and test these assessments in populations from at least three different diseases or conditions. Partnerships with non-profit patient advocacy organizations and engagement with people with lived experience (PWLE) are mandatory to ensure meaningful, community-informed research and to facilitate adoption.
The funding mechanism is a phased UG3/UH3 cooperative agreement:
- UG3 phase (1–2 years): Technical development, analytical validation, and pilot studies.
- UH3 phase (3–4 years): Prospective longitudinal clinical validation in representative populations.
The program is open to clinical trial proposals and is designed to encourage cross-disease collaboration, resource pooling, and the generation of robust, generalizable digital endpoints for future clinical trials.
