Milestone Announcement: The IDEA-FAST consortium has published its major Clinical Study Protocol in DIGITAL HEALTH! This is one of the project’s most important publications to date!
This paper outlines the IDEA-FAST Clinical Observational Study (COS). The IDEA-FAST COS, building on a preceding Feasibility Study and qualification advice of the European Medicines Agency, investigates the relationship between digital and clinical parameters for the target concepts of fatigue, reduced sleep quality, and daytime sleepiness.
Between 2022 and 2025, almost 2000 people were recruited across Europe. Participants are followed over a 24-week period with four visits, each including a 1-week assessment phase at home using CE-certified digital health (including active and passive) technologies. The latter collect information on physical activity, physiology, cognition, as well as social interaction and behaviour as core dimensions of the target concepts.
Why read it?
This protocol provides a detailed roadmap for integrating digital health technologies into large-scale clinical settings. It offers insights into study design, patient monitoring, and regulatory considerations that can serve as a benchmark for future digital biomarker research. We are one step closer to making clinical trials more efficient and less burdensome for patients.
Read the full article and find out more about the COS here.