IDEA-FAST: Identifying digital endpoints for fatigue and sleep for people living with chronic conditions

Digital Health

Collaborators 46 members from pharmaceutical companies, academic & not-for-profit institutions, small-and-medium-sized enterprises and patient organisations

Abstract

Open Lab is involved in IDEA-FAST a new European research project to Identify Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living for people living with chronic conditions such as Parkinson’s disease and Huntington’s disease.

Method

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.

Takeaways

The ambitious goal of the project is to provide more objective, sensitive, reliable and ecological measures of the severity and impact of these symptoms in real-world settings.

Open Lab is involved in IDEA-FAST a new European research project to Identify Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living (acronym: IDEA-FAST) in the following neurodegenerative disorders (NDD): Parkinson’s disease and Huntington’s disease and in the following immune-mediated inflammatory diseases (IMID): rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren’s syndrome, and inflammatory bowel disease; has been launched.

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.

Measuring fatigue and sleep disturbances

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.

Open Lab will lead the work to select the devices and accompanying software, develop a smartphone app for patients to use and support the design of the large-scale data management platform.

Partners

The IDEA-FAST project involves: Abbvie Inc., Asociación Parkinson Madrid,AstraZeneca AB, Biogen IDEC Ltd, Byteflies NV, CHDI Foundation, Cambridge Cognition Ltd, Dreem, ECRIN European Clinical Research Infrastructure Network, Eli Lilly & Co. Ltd., Erasmus Universitair Medisch Centrum Rotterdam, European Federation of Crohn's & Ulcerative Colitis Association,F. Hoffmann-La Roche AG, FCiências. ID – Associação para a Investigação e Desenvolvimento de Ciências, George-Huntington-Institut GmbH, Imperial College of Science Technology and Medicine, Institut Mines-Télécom, Institute of Psychiatry and Neurology, Instituto de Medicina Molecular Joao Lobo Antunes, Janssen Pharmaceuticals NV, Leiden University Medical Centre, Lixoft SAS,Masters and Scholars of the University of Cambridge, McRoberts BV, Medibiosense Ltd, Medical University of Innsbruck, Orion OYJ., Parkinson’s Disease Society of the United Kingdom, Pfizer Ltd, Pluribus One S.r.l, Queen Mary University of London, Sanofi Aventis Recherche et Développement, Stavanger University Hospital, Stichting MLC Foundation, TMF – Technologie und Methodenplattform für die Vernetzte Medizinische Forschung e.V, Takeda Pharmaceuticals International AG, The Chancellor, UCB Biopharma SPRL, Universidad Autonoma de Madrid, Universita Degli Studi di Brescia,University of Glasgow, University of Limerick, University of Manchester, University of Newcastle upon Tyne, Universtätsklinikum Schleswig-Holstein (Kiel), VTT Technical Research Centre of Finland Ltd, empirica Gesellschaft für Kommunikations und Technologieforschung mbH mbH, iXscient Ltd.