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
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.
Showcase project outputs and other disseminations, and presentation of the finalised data package to obtain scientific advice and approval from the EMA/FDA.
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
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,
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
We are excited to announce the upcoming webinar by IDEA-FAST, which will be held on 7 June 2023 from 2:00 to 4:00 PM CET. This informative session will explore the latest advancements in research, and
We’re thrilled to announce that the final event report for the multi-stakeholder workshop on Enhancing Patient-Centric Outcome Measures and Clinical Trials with Digital Health Technologies, organized by the European Federation of Pharmaceutical Industries and Associations
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 (europa.eu) IHI
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.