Findings
Digital health technologies can provide more granular, continuous, and sensitive measures compared to traditional clinical assessments.
Digital measurements can detect treatment responses earlier and with smaller sample sizes than traditional methods.
There is a lack of standardized endpoints and insufficient data to contextualize findings from digital measurements.
Recommendations
Utilize digital health technologies to increase research efficiency and reduce trial participation burden.
Develop frameworks for regulatory acceptance of digital endpoints.
Continue research to establish meaningful changes9 and standardize endpoints based on digital measurements.
Regulatory Considerations
Establish evidentiary criteria for using digital measurements as surrogate endpoints.
Address the need for regulatory frameworks to support the use of digital health technologies in clinical trials.