Development of Digital Biomarkers and Endpoints for Clinical Cancer Care

Fast-Track proposals will NOT be accepted. Direct-to-Phase II proposals will be accepted. Number of anticipated awards: 2-4 Budget (total costs, per award): Phase I: up to $400,000 for up to 12 months Phase II: up to $2,250,000 for up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Summary Digital health technologies (DHTs) include a diverse range of tools capable of measuring physiological signals relevant to cancer including movement, sleep, heart rate, body temperature, and oxygen level. Additionally, DHTs can capture biological signatures from sweat and interstitial fluids such as metabolites and electrolytes. For individuals with cancer and their health care providers, DHTs offer tremendous opportunity to remotely monitor physiological status between clinical visits, leading to more prompt medical intervention and improved clinical outcomes. The data collected by DHTs can also be Page 101 used to generate digital biomarkers, which are characteristic(s) collected from one or more DHTs that are measured as an indicator of normal biological or pathogenic processes, or responses to an exposure or intervention. Digital biomarkers can be used to complement standard assessments (e.g., labs, patient reported outcomes) to provide novel insights into treatment tolerance, toxicities, and inform digital endpoints (precisely defined variables that reflect clinical outcomes). Despite the immense potential of DHTs, their adoption in clinical cancer care has lagged that of other disease areas such as cardiovascular disease due to the limited availability of cancer-specific DHT-derived biomarkers and endpoints that have demonstrated clinical and analytical validity. There is an unmet need to leverage the numerous DHTs, analytical platforms, and sophisticated informatics techniques to develop digital biomarkers and endpoints for improved cancer patient care and outcomes, especially in patients in medically underserved or rural areas.