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

The purpose of this Notice of Funding Announcement (NOFO) is to support the development of biomarkers or clinical outcomes derived from digital health technology (DHT) for use in clinical trials for remote monitoring as primary or secondary endpoints. To improve clinical impact, increase statistical feasibility, and promote standardization, applicants will be expected to develop and test the digitally derived assessments in populations from at least three different diseases or conditions. Partnerships with non-profit patient advocacy organizations will be required. Key aspects of this opportunity include: • Development of biomarkers or clinical outcomes from digital health technology • Use in clinical trials for remote monitoring • Partnerships with non-profit patient advocacy organizations • Expected to test digitally derived assessments in populations from at least three different diseases or conditions • Improvement of clinical impact, statistical feasibility, and standardization