Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development (UG3/UH3 - Clinical Trial Optional) - PAR-25-170
Funder
National Institutes of Health
LOI Deadline
;
;
LOI Required
Recommended, but not required
Application Deadline
;
;
;
Maximum Project Duration
5 years
Research Focus Areas
Alzheimer’s Disease, Dementia, and Neurocognitive Disorders
Bipolar Disorders
Biomarkers
Clinical
Digital Health/Mobile Technologies
Neurobiology/Neuroscience
Trauma and Stress-Related Disorders
Research Methods
Randomized Control Trials (RCT)
Mobile Technologies/Other Digital Health
Description
The purpose of this notice of funding opportunity (NOFO) is to support rigorous development and validation of Digital Health Technology (DHT) derived biomarkers or clinical outcome assessments (COAs) for remote monitoring to fill a defined unmet clinical endpoint for interventional clinical trials. To increase standardization and improve clinical adoption, applicants must propose to develop and evaluate the DHT enabled biomarkers or COAs in three or more diseases or conditions. Applicants must also propose to conduct development studies that are informed by people with lived experience (PWLE) and patient advocacy organizations. The first phase of this funding mechanism is to evaluate the technical performance of the proposed DHTs withPWLE input; the second phase is to support a prospective longitudinal clinical study in representative populations to validate the DHT. Research outcomes should include demonstrating how a meaningful change in the biomarkers or COAs derived from the DHT(s) can be statistically measured and quantified at the individual participant level.