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New CTTI Project Aims to Increase the Use of Clinical Trial Endpoints Derived from Digital Technologies

While digital health technologies (DHT) offer clinical trial researchers the promise of more efficient and potentially accurate data, there are very few examples of digitally derived primary endpoints that can support regulatory labeling claims.


To address this issue, CTTI is conducting a new project that will build on previous novel endpoint work to create additional resources and recommendations to drive the use of digitally derived, functional outcomes as key endpoints in clinical trials to support regulatory decision-making.


Once the project is complete, stakeholders can look forward to resources such as:

  • Best practice recommendations on the “standards of evidence” needed to qualify a DHT-derived novel endpoint
  • Glossary of terms for digital health endpoints
  • Summary of interview results
  • Proposed enhancements to a FDA COA roadmap that incorporates digitally derived endpoint considerations
  • Expert meeting summary

CTTI will conduct glossary term evaluations, literature reviews, and landscape assessments – as well as in-depth interviews and multi-stakeholder expert meetings – to collect data that will inform the new recommendations and resources.


These solutions will serve to increase the use of meaningful DHT-derived novel endpoints in clinical trials for labeling claims and help to advance the benefits of running digital health trials, including the capture of more meaningful and higher quality research data.