IDEA-FAST Final Conference
Join us at the IDEA-FAST Final Conference, taking place on Wednesday, 17 June 2026, in Hamburg and online. The IDEA-FAST project is an IMI2 initiative launched in November 2019, bringing together 48 partners across 15
The aim of the Feasibility Study (FS) is to gather information on a variety of potential digital measures captured with different devices and their ability to reflect sleep disturbances or fatigue. The preparation phase includes the concept design of the study, the technical specifications, and assessment of the stepwise development of the study.
Recruitment of participants across 6 diseases cohorts in four clinical sites, device usage data collection, and biomarker evaluation. The FS outcomes are integral in the development and optimisation of the Clinical Observation Study (COS).
2 Meetings with the EMA’s Innovation Task Force (ITF) to consolidate the FS protocol, FS data analysis, COS protocol and development.
Results from the FS are used to develop the plan for the COS: the design of the study, specifications regarding participant recruitment and device usage, data collection, and data analysis.
2000 participants with a variety of neurodegenerative and immune-mediated inflammatory conditions across 22 sites are recruited and monitored for 6 months while using digital devices. The results from COS are instrumental in meeting the challenge of developing composite digital endpoints to assess fatigue and sleep disturbances.
During this period, interim analyses of the collected COS data are conducted to identify potential digital biomarkers. These analyses help refine the selection of the most promising digital endpoints for assessing fatigue and sleep disturbances.
Based on the interim data analysis, a final set of digital biomarkers is selected. These biomarkers will form the basis for further regulatory validation and potential adoption in clinical trials.
The selected digital biomarkers undergo rigorous evaluation to ensure their validity, reliability, and clinical relevance.
All data collected during the COS is finalized and locked to data integrity for subsequent regulatory submission and scientific analysis.
Showcase project outputs and other disseminations, and presentation of the finalised data package to obtain scientific advice and approval from the EMA/FDA.
Join us at the IDEA-FAST Final Conference, taking place on Wednesday, 17 June 2026, in Hamburg and online. The IDEA-FAST project is an IMI2 initiative launched in November 2019, bringing together 48 partners across 15
On 31 January 2026, the final IDEA-FAST Clinical Observation Study participant completed their last visit, marking the official end of our COS, with a total of 1,887 participants across all study sites. IDEA-FAST marks one
As 2025 draws to a close, we would like to extend our heartfelt gratitude to all our consortium members, partners, and supporters. This has been a year full of challenges, but also many successes for
Clinicians: How do you assess fatigue and sleep in your patients? Current tools to evaluate fatigue and sleep disturbances rely heavily on subjective reports — which can miss daily fluctuations and the broader impact on
Fatigue and sleep disturbances are among the most disabling symptoms for people living with chronic conditions — yet they remain difficult to measure and manage. The IDEA-FAST project, a Europe-wide research initiative, is exploring how
We are proud to announce that the latest edition of the IDEA-FAST Newsletter is here! Check out some of the highlights:– Over 1700 participants recruited in our Clinical Observation Study, thanks to the hard work