Neuronet is a Coordination and Support Action (CSA) aiming to support and better integrate projects in the Innovative Medicines Initiative (IMI) Neurodegenerative Disorders (ND) portfolio. Currently, the IMI ND portfolio includes 18 projects covering a number of neurodegenerative disease conditions. We are happy to welcome the IDEA-FAST project in the Neuronet programme.
IDEA-FAST is a ground-breaking, €42 million digital health project co-funded by the European Union (represented by the European Commission) and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations) under the Innovative Medicines Initiative Joint Undertaking (IMI JU) programme. It consists of 46 members from 14 different European countries, including pharmaceutical companies, academic & not-for-profit institutions, small- and medium-sized enterprises and patient organisations aimed to play complementary roles in achieving the agreed goals.
Fatigue and sleep disturbances are common and disabling symptoms that affect patients with NDD and IMID, impacting on daily activities; they are the major causes of poor quality of life and increased healthcare cost. Current questionnaire-based approaches to measure these symptoms have key limitations preventing them from being used as reliable endpoints in clinical trials to evaluate the effect of therapies.
Based on the advancement of wearable and portable digital technology, IDEA-FAST aims to address these issues by identifying novel digital endpoints for fatigue, sleep disturbances and disabilities in daily activities. The final ambitious goal is to provide more objective, sensitive, reliable and ecological measures of the severity and impact of these symptoms in real-world settings. Such digital endpoints will eventually improve the efficiency of clinical trials, ultimately reducing the time and cost to bringing new therapies to patients.
The project will run for 66 months, consisting of 2 phases: an initial pilot study for testing and prioritising several digital devices and to identify candidate digital endpoints, followed by a large longitudinal study to validate findings for the most promising digital endpoints. The project will seek advice from regulatory agencies, including EMA, for the initial qualification of these digital endpoints. Patient users’ perspective, data privacy, ethical, legal and other regulatory issues will be taken into consideration at all stages of the project.
Walter Maetzler (University Of Kiel) is IDEA-FAST representative on Neuronet’s Scientific Coordination Board.