IDEA-FAST

Identifying digital endpoints to assess fatigue, sleep and activities in daily living in neurodegenerative disorders and immune-mediated inflammatory diseases

Summary

Fatigue and sleep disturbances are common symptoms of many chronic diseases, and are associated with a poor quality of life and greater healthcare costs. Today, efforts to measure these symptoms, e.g. in clinical trials, are based largely on standardised paper questionnaires, which do not give very reliable results.

The aim of IDEA-FAST is to identify digital endpoints for fatigue and sleep disturbances that will provide a more sensitive, reliable measure of the severity and impact of these symptoms in a real life setting. They will do this by identifying the characteristics of fatigue and sleep disturbances and the digital endpoints that could quantify them. They will then select the digital devices and technologies that could measure and record these symptoms. They will also design a secure digital management platform to support the acquisition, storage and analysis of the data.

All of this will be validated in a pilot study involving patients with neurodegenerative diseases (Parkinson’s disease and Huntington’s disease) and immune-mediated inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren’s syndrome, and inflammatory bowel disease).

In addition to gaining new insights into the mechanisms behind fatigue and sleep disturbances, IDEA-FAST’s results should dramatically improve the efficiency of clinical trials, and so speed up the development of new treatments for these chronic diseases.

Achievements & News

Digital biomarkers: an initiative to help researchers navigate new reality and roles

Mobilise-D and IDEA-FAST have created the Digital Health Catalyst (DHC) in response to the growing need for research and application in the area of real-world digital measurements. ###According to a Lynn Rochester, coordinator of Mobilise-D and Wan Fai Ng, coordinator of IDEA-FAST, the DHC intends to foster the next generation of early career researchers and clinicians in the field of digital healthcare. It will bring together ‘the collective expertise in digital health across the two IMI consortia for maximum learning, collaboration and impact’.

Accepted methods like questionnaires are subjective and don’t quite capture changes in the severity of a person’s condition. If remote assessment and the use of digital biomarkers as indicators of health are to be adopted widely, priorities will have to be established with regards to education and training, career pathways, cross-disciplinary opportunities and requirements for support and development. During the DHC launch event, early career researchers listed their priorities as skills development, exchange programmes and internships, engaging with the various relevant stakeholders and attending seminars.

The DHC will be a standalone sustainable entity that can attract funding and expand its remit to additional areas to promote and catalyse the field of digital health.

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Mobilise-D and IDEA-FAST team up on digital health technologies

Mobilise-D and IDEA-FAST, two IMI projects that aim to develop real-world digital outcomes, have announced their plan to collaborate, to bring synergy and increase the impact and benefits of the digital health technologies developed by both projects. ###The collaboration will exploit common themes and approaches across the projects, to develop digital biomarkers in mobility, sleep and fatigue, including large observational studies involving diverse patient cohorts. The topics of collaboration include areas such as ethics, principles of external data-sharing, regulatory approaches, dissemination activities, training and education, and working with stakeholders.

Professors Lynn Rochester and Wan-Fai Ng from Newcastle University, the coordinators of Mobilise-D and IDEA-FAST respectively, state: ‘We are delighted with this collaboration which cements the intended relationship seen from the inception of the projects, and look forward to the extended impact and reach possible by formalising our ongoing collaboration.’

For their part, the projects’ EFPIA leads, Dr Ronenn Roubenoff (Novartis, Mobilise-D) and Dr Frederic Baribaud (Janssen, IDEA-FAST) identify the future benefits of the inclusion of digital biomarker approach in clinical trials to develop and evaluate pharmaceutical interventions.

Professor Walter Maetzler, who participates in both projects commented: ‘What could be more advantageous than to consistently combine the strengths of both projects and thus increase the impact for patients and medicine?’

Mobilise-D focuses on mobility assessment in chronic obstructive pulmonary disease, Parkinson’s disease, multiple sclerosis and proximal femoral fracture and IDEA-FAST on the assessment of fatigue, sleep disturbances and instrumental activities in neurodegenerative disorders (Parkinson’s disease, Huntington’s disease) and immune-mediated inflammatory diseases (inflammatory bowel diseases, lupus, rheumatoid arthritis, Sjogren’s syndrome). Both projects aim to develop and validate digital biomarkers towards regulatory approvals.

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Unravelling the enigma of autoimmune diseases – an opinion piece by Pierre Meulien

We like to think of the immune system as a surveillance mechanism for the body that’s standing guard, ready to weed out and kill anything harmful. But for people with an autoimmune disorder, it doesn’t work that way; deregulated, it fights our own tissue instead of protecting it. ###And while we might have some success in treating the symptoms, we are largely in the dark as to why treatments work for some and not for others, as well as what triggers the disease in the first place. In an opinion piece published on the IMI website, IMI Executive Director Pierre Meulien explores IMI’s portfolio in this important disease area.

‘One of things that IMI is particularly proud of is the progress we’ve made in the reclassification of subtypes of disease, which means redefining diseases based on their biology and not just symptoms,’ he writes. ‘It’s an extremely scientifically complex area, and we’re steadily increasing the level of understanding of the molecular drivers in a number of disease areas.’

IMI is also very active in remote assessment. ‘This tech convergence is a trend, and we will see more and more sophisticated remote monitoring which will change the game in clinical trials,’ writes Dr Meulien, citing IMI’s Trials@Home and IDEA-FAST projects.

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Participants

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EFPIA companies
  • Abbvie Inc, North Chicago, Illinois, United States
  • Astrazeneca AB, Södertälje, Sweden
  • Biogen Idec Limited, Maidenhead, Berkshire, United Kingdom
  • Bristol-Myers Squibb Company Corp, Princeton, NJ, United States
  • Eli Lilly And Company LTD, Basingstoke, United Kingdom
  • F. Hoffmann-La Roche AG, Basel, Switzerland
  • Janssen Pharmaceutica Nv, Beerse, Belgium
  • Orion Oyj, Espoo, Finland
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
  • Takeda Pharmaceuticals International AG, Glattpark-Opfikon (Zurich), Switzerland
  • UCB Biopharma, Brussels, Belgium
Universities, research organisations, public bodies, non-profit groups
  • Academisch Ziekenhuis Leiden, Leiden, Netherlands
  • Ecrin European Clinical Research Infrastructure Network, Paris, France
  • Erasmus Universitair Medisch Centrum Rotterdam, Rotterdam, Netherlands
  • Fciencias.Id - Associacao Para A Investigacao E Desenvolvimento De Ciencias, Lisbon, Portugal
  • Helse Stavanger Hf, Stavanger, Norway
  • Imperial College Of Science Technology And Medicine, London, United Kingdom
  • Institut Mines-Telecom, Paris, France
  • Instituto De Medicina Molecular Joao Lobo Antunes, Lisboa, Portugal
  • Instytut Psychiatrii I Neurologii, Warszawa, Poland
  • Medizinische Universitat Innsbruck, Innsbruck, Austria
  • Queen Mary University Of London, London, United Kingdom
  • Teknologian Tutkimuskeskus Vtt Oy, Espoo, Finland
  • The University Of Manchester, Manchester, United Kingdom
  • Tmf - Technologie Und Methodenplattform Fur Die Vernetzte Medizinische Forschung Ev, Berlin, Germany
  • Universidad Autonoma De Madrid, Madrid, Spain
  • Universita Degli Studi Di Brescia, Brescia, Italy
  • Universitatsklinikum Schleswig-Holstein, Lübeck, Germany
  • University College Cork - National University Of Ireland, Cork, Cork, Ireland
  • University Of Glasgow, Glasgow, United Kingdom
  • University Of Limerick, Limerick, Ireland
  • University Of Newcastle Upon Tyne, Newcastle upon Tyne, United Kingdom
  • University of Cambridge, Cambridge, United Kingdom
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Byteflies, Antwerpen, Belgium
  • Cambridge Cognition Limited, Cambridge, United Kingdom
  • Empirica Gesellschaft Fur Kommunikations Und Technologieforschung Mbh, Bonn, Germany
  • George-Huntington-Institut GMBH, Munster, Germany
  • Ixscient Limited, Uxbridge, United Kingdom
  • Let It Care, Antony, France
  • Mcroberts BV, S Gravenhage, Netherlands
  • Medibiosense LTD, Doncaster, United Kingdom
  • Pluribus One SRL, Cagliari, Italy
  • Stichting Lygature, Utrecht, Netherlands
Patient organisations
  • Asociacion Parkinson Madrid, Madrid, Spain
  • European Federation Of Crohn'S And Ulcerative Colitis Associations, Bruxelles, Belgium
Associated partners
  • Parkinson'S Disease Society Of Theunited Kingdom Lbg, London, United Kingdom
Third parties
  • Christian-Albrechts-Universitaet Zu Kiel, Kiel, Germany
  • Faculdade De Ciencias Da Universidade De Lisboa, Lisboa, Portugal
  • Fundacion Para La Investigacion Biomedica Del Hospital Universitario Clinico San Carlos, Madrid, Spain
  • Greater Glasgow Health Board, Glasgow, United Kingdom
  • Kks-Netzwerk Ev -Netzwerk Der Koordinierungszentren Fur Klinische Studien, Berlin, Germany
  • UNIVERSITAET zu LUEBECK, Luebeck, Germany
Non EFPIA companies
  • CHDI Foundation, Inc., New York, United States

Participants
NameEU funding in €
Academisch Ziekenhuis Leiden134 500
Asociacion Parkinson Madrid250 000
Byteflies199 915
Cambridge Cognition Limited150 000
Dreem (left the project)90 641
Ecrin European Clinical Research Infrastructure Network380 625
Empirica Gesellschaft Fur Kommunikations Und Technologieforschung Mbh473 750
Erasmus Universitair Medisch Centrum Rotterdam439 500
European Federation Of Crohn'S And Ulcerative Colitis Associations35 000
Fciencias.Id - Associacao Para A Investigacao E Desenvolvimento De Ciencias285 000
George-Huntington-Institut GMBH328 075
Helse Stavanger Hf319 500
Imperial College Of Science Technology And Medicine2 345 530
Institut Mines-Telecom356 750
Instituto De Medicina Molecular Joao Lobo Antunes289 500
Instytut Psychiatrii I Neurologii140 000
Ixscient Limited400 750
Let It Care297 161
Lixoft SAS (left the project)242 776
Mcroberts BV181 755
Medibiosense LTD764 703
Medizinische Universitat Innsbruck290 625
Pluribus One SRL287 500
Queen Mary University Of London304 000
Stichting Lygature401 485
Stichting Mlc Foundation (left the project)200 000
Teknologian Tutkimuskeskus Vtt Oy685 141
The University Of Manchester167 500
Tmf - Technologie Und Methodenplattform Fur Die Vernetzte Medizinische Forschung Ev360 000
Universidad Autonoma De Madrid120 000
Universita Degli Studi Di Brescia711 500
Universitatsklinikum Schleswig-Holstein3 020 639
University College Cork - National University Of Ireland, Cork355 113
University of Cambridge595 165
University Of Glasgow196 921
University Of Limerick112 225
University Of Newcastle Upon Tyne4 548 467
 
Third parties
NameFunding in €
Faculdade De Ciencias Da Universidade De Lisboa65 000
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Clinico San Carlos49 033
Greater Glasgow Health Board52 079
Kks-Netzwerk Ev -Netzwerk Der Koordinierungszentren Fur Klinische Studien90 000
UNIVERSITAET zu LUEBECK240 000
University College Cork - National University Of Ireland, Cork (left the project)39 700
 
Total Cost20 997 524