IDEA-FAST Timeline

November 2019 - August 2020
Feasibility Study Preparation

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.

July 2020 - May 2021
Feasibility 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).

2020 - 2022
EMA Interactions

2 Meetings with the EMA’s Innovation Task Force (ITF) to consolidate the FS protocol, FS data analysis, COS protocol and development.  

May 2021 - April 2022
Clinical Observation Study Preparation

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.

April 2022 - August 2024
Clinical Observation Study

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.

April 2025
Final Data Package

Showcase project outputs and other disseminations, and presentation of the finalised data package to obtain scientific advice and approval from the EMA/FDA.

Latest News

#1 Newsletter of the IDEA-FAST COS

Dear readers, The Clinical Observation Study (COS) is on a roll, and we are proud to present the first Newsletter of the IDEA-FAST COS, with the latest recruitment status. The COS is an ambitious study

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