Regulatory Qualification of a Cross-DiseaseDigital Measure: Benefits and Challenges fromthe Perspective of IMI Consortium IDEA-FAST

IDEA-FAST is developing novel digital endpoints to assess fatigue, sleep quality, and impact of sleep disturbances in patients with neurodegenerative diseases and immune-mediated inflammatory diseases. In 2022, the project’s consortium met with the European Medicines Agency (EMA) to get advice on its plans for regulatory qualification of the measures.This paper reviews the IDEA-FAST view on developing digital measures for multiple diseases and the advice provided by the EMA.

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853981. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and PARKINSON’S DISEASE SOCIETY OF THE UNITED KINGDOM LBG.