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

World IBD Day 2023

On Friday was World IBD Day! 💜 It’s the day when patient organisations, patients, families, supporters and many other stakeholders join forces to raise awareness of Inflammatory Bowel Disease (IBD)  and how it impacts the

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IDEA-FAST Mid-term Achievements Report

The IDEA-FAST mid-term achievements report is here! We would like to say a big thank you to all IDEA-FAST partners for their contribution and dedication to the IDEA-FAST project. Although the Covid-19 pandemic has eased,

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IDEA-FAST on the USA Digital Biomarker Summit

The Digital Biomarker Summit USA will bring together industry leaders who will present the work that is currently underway with DHTs and digital biomarkers, aiming to drive the industry forward through education and collaboration. This

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IDEA-FAST Featured in IHI

We are proud to have one of our latest publications featured by the Innovative Health Inntiative (IHI). Find out more here: Wearable technologies can reliably measure fatigue and disturbed sleep in chronic disease ( IHI

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