Jessilyn Dunn Moderates Session at FDA Public Workshop

This morning, Dr. Jessilyn Dunn moderated a session with FDA experts at Statistical Considerations for Digitally-Derived Endpoints in Clinical Trials, a virtual public workshop hosted by the FDA and convened by the Duke-Margolis Institute for Health Policy.

The session explored how continuous glucose monitoring (CGM) technical specifications can inform regulatory submissions, device evaluation, and analytical best practices for digitally derived endpoints. The discussion also highlighted how lessons from CGM data in clinical trials may help advance the broader use of digital health technologies in drug development and regulatory decision-making.

Thank you to the experts who presented during this session: Yoonhee Kim, Hye Soo Cho, Yiduo Wu, and Irina Gaynanova!

Learn more about the workshop here: https://healthpolicy.duke.edu/events/statistical-considerations-digitally-derived-endpoints-clinical-trials

#DigitalHealth #ClinicalTrials #Wearables #CGM #FDA #DigitalEndpoints #BiomedicalEngineering