Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development (UG3/UH3 - Clinical Trial Optional)

The funding opportunity titled "Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development" UG3/UH3 - Clinical Trial Optional is issued by the National Institutes of Health, including participating organizations such as the National Institute of Neurological Disorders and Stroke, the National Cancer Institute, and the National Institute on Aging. This notice of funding opportunity aims to support the development and validation of digital health technology-derived biomarkers or clinical outcome assessments for remote monitoring. These tools are expected to address unmet clinical endpoints in interventional clinical trials by being evaluated across three or more diseases or conditions. The project will incorporate the input of people with lived experience and patient advocacy organizations. The first UG3 phase focuses on the technical performance and optimization of the proposed digital technologies, while the UH3 phase involves prospective longitudinal clinical studies to validate their use. The overarching goals of this program include reducing participant burden in clinical trials, improving endpoint standardization, and enhancing the sensitivity of assessments to detect meaningful changes over time. Digital health technologies such as wearable devices, sensor-based tools, and web-based applications will be evaluated. Applicants must address feasibility, regulatory considerations, and the contexts of use for their proposed biomarkers or clinical assessments. The initiative emphasizes the need for rigorous scientific methods, analytical validation, and community engagement to ensure the proposed endpoints are meaningful and broadly adoptable. Eligible applicants include higher education institutions, nonprofit organizations, for-profit organizations, small businesses, local governments, tribal organizations, and others as specified. Foreign organizations are not eligible to apply, although foreign components of US-based organizations may be included. The total project period cannot exceed five years, with the UG3 phase lasting one to two years and the UH3 phase lasting three to four years. Application budgets are not capped but must align with project needs. A letter of intent is requested 30 days before the application due date, with the first due date being February 21, 2025. Subsequent application cycles occur in June 2025, February 2026, and June 2026. Applications must include a detailed research strategy, quantitative milestones for go/no-go decisions, and a community engagement plan. Teams should demonstrate expertise in clinical science, regulatory processes, data analysis, and disease-specific areas. Successful proposals will address the unmet need for remote monitoring endpoints, justify the proposed biomarkers or assessments, and include robust statistical methods for data analysis. Collaboration with regulatory agencies such as the FDA is encouraged to align validation studies with regulatory expectations. The review process will evaluate the significance, innovation, rigor, feasibility, and expertise of the research team. Specific evaluation factors include the importance of the proposed endpoints, the ability to address current clinical gaps, and the likelihood of achieving meaningful and validated outcomes. Applications that do not meet program requirements, such as a lack of milestone plans or a failure to address three or more diseases, will be considered non-responsive. The program emphasizes adherence to NIH policies for data management and sharing, as well as transparency in research practices. Awardees are expected to share their findings through public repositories to enable reproducibility and further research. Key dates include an expiration date of June 23, 2026, with an anticipated earliest start date of December 2025 for the first application cycle. Potential applicants are encouraged to contact NIH scientific and grants management staff prior to submission to ensure alignment with program priorities.