Mobility – how well we walk – is an important marker of health; a slow walking speed is associated with a greater risk of disease, cognitive decline, risk of falls and even earlier death. As the population ages, the number of people experiencing mobility issues is expected to rise. However, accurately assessing people’s mobility, especially in the real world, is far from easy. MOBILISE-D aims to develop a comprehensive system to analyse people’s gait based on digital technologies, including sensors worn on the body. The project focuses on conditions which often affect mobility, namely chronic obstructive pulmonary disease (COPD), Parkinson’s disease, multiple sclerosis, hip fracture recovery, and congestive heart failure. The project plans to work closely with regulators and other stakeholders to ensure that the solutions are accepted. Once validated, the MOBILISE-D results will help to improve the accurate assessment of mobility in clinical trials. They will also make it easier for clinicians to monitor patients’ mobility and thereby contribute to improved, more personalised care.
Achievements & News
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, 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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Reduced walking speed is a sign of many health conditions. The Mobilise-D project wants to make continuous digital measurements of the way a person walks, gathered using wearable sensor technology, accepted as valid indicators of their state of health, much in the same way as blood pressure readings or oxygen levels are. Now the project has received an early public nod of support for their working methods and plans from the European regulator, the European Medicines Agency (EMA).###
Mobilise-D’s mission is to get these digital mobility outcomes, or DMOs, ‘qualified’ to be used as biomarkers in clinical trials. It’s an ambitious goal and they are using five different diseases as test cases. The letter of support – an intermediary sign of encouragement from the EMA on the way to full qualification - is important because it demonstrates not only the promise of the innovation, but also how important it is to build rapport with the regulating authorities early, something IMI encourages in all our funded research.
At the very start of Mobilise-D, the consortium made a strategic plan on how to get regulatory acceptance for DMOs. They decided to interact with the EMA very early on by submitting a request for qualification advice, and to take an incremental approach, starting with qualification advice of monitoring biomarkers in Parkinson’s disease.
Early interactions with regulators are particularly valuable in young and evolving fields like digital health technologies, where the regulatory framework is still under development and many things are still uncertain. The consortium’s step-by-step approach is also critical for maximising the chances of success, because it allows them to refine their plans as they gain more knowledge. With this positive feedback, Mobilise-D can progress confidently with their work.
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Digital technologies are playing an increasingly significant role in health research and healthcare, but debates about how best to get regulatory approval for these technologies are ongoing. Now, partners in IMI’s Mobilise-D project have set up a discussion channel on Slack called #dHealth4Trials to facilitate discussions### on good practices in the use of in silico and digital technologies in clinical practice and in the regulatory evaluation of new drugs and medical devices.
The new channel is part of the wider In Silico World Community of Practice, and is open to anyone with a professional or educational interest in in silico medicine and digital health, including researchers from academia and industry as well as regulators, policy makers and patients’ representatives.
‘The #dHealth4Trials channel will provide to all practitioners an online community of practice where pre-competitive information can be exchanged freely,’ said Marco Viceconti, founder of In Silico World ‘We believe this is an essential step to accelerate the adoption of digital technologies in regulatory trials: this community of experts, in collaboration with experts from regulatory agencies worldwide, could develop good qualification practices for the qualification of digital health methodologies.’
The discussion is highly relevant to Mobilise-D, which is assessing the use of digital technologies to assess people’s mobility and has requested qualification advice from the European Medicines Agency (EMA) on this.
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ParticipantsShow participants on map
- Amgen, Brussels, Belgium
- Astrazeneca AB, Södertälje, Sweden
- Bayer Aktiengesellschaft, Leverkusen, Germany
- Eresearch Technology Inc, Philadelphia, United States
- Grunenthal GMBH, Aachen, Germany
- Icon Clinical Research Limited, Dublin, Ireland
- Merck Kommanditgesellschaft Auf Aktien, Darmstadt, Germany
- Novartis Pharma AG, Basel, Switzerland
- Pfizer Limited, Sandwich, Kent , United Kingdom
- Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
- Takeda Pharmaceuticals International AG, Glattpark-Opfikon (Zurich), Switzerland
- Teva Pharmaceutical Industries Limited, Netanya, Israel
Universities, research organisations, public bodies, non-profit groups
- Alma Mater Studiorum - Universita Di Bologna, Bologna, Italy
- Centre Hospitalier Universitaire Montpellier, Montpellier, France
- Christian-Albrechts-Universitaet Zu Kiel, Kiel, Germany
- Ecole Polytechnique Federale De Lausanne, Lausanne, Switzerland
- Friedrich-Alexander-Universitaet Erlangen-Nuernberg, Erlangen, Germany
- Fundacion Privada Instituto De Salud Global Barcelona, Barcelona, Spain
- Imperial College Of Science Technology And Medicine, London, United Kingdom
- Katholieke Universiteit Leuven, Leuven, Belgium
- Norges teknisk-naturvitenskapelige universitet - NTNU, Trondheim, Norway
- Robert Bosch Gesellschaft Fur Medizinische Forschung Mbh, Stuttgart, Germany
- The Foundation For Medical Research Infrastructural Development And Health Services Next To The Medical Center Tel Aviv, Tel Aviv, Israel
- The University Of Sheffield, Sheffield, United Kingdom
- Universita Degli Studi Di Sassari, Sassari, Italy
- Universita Vita-Salute San Raffaele, Milano, Italy
- Universitat Zurich, Zürich, Switzerland
- Universitatsklinikum Erlangen, Erlangen, Germany
- University College Dublin, National University Of Ireland, Dublin, Dublin, Ireland
- University Of Newcastle Upon Tyne, Newcastle upon Tyne, United Kingdom
- University Of Northumbria At Newcastle, Newcastle upon Tyne, United Kingdom
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
- Ixscient Limited, Uxbridge, United Kingdom
- Mcroberts BV, S Gravenhage, Netherlands
- Penumologisches Forschungsinstitutan Der Lungenclinic Grosshansdorf GMBH, Grosshansdorf, Germany
- Sheffield Teaching Hospitals Nhs Foundation Trust, Sheffield, United Kingdom
- The Newcastle Upon Tyne Hospitals Nhs Foundation Trust, Newcastle-Upon-Tyne, United Kingdom
|Name||EU funding in €|
|Alma Mater Studiorum - Universita Di Bologna||855 665|
|Centre Hospitalier Universitaire Montpellier||464 685|
|Christian-Albrechts-Universitaet Zu Kiel||1 072 069|
|Ecole Polytechnique Federale De Lausanne||993 625|
|Friedrich-Alexander-Universitaet Erlangen-Nuernberg||847 864|
|Fundacion Privada Instituto De Salud Global Barcelona||1 614 656|
|Imperial College Of Science Technology And Medicine||390 540|
|Ixscient Limited||464 000|
|Katholieke Universiteit Leuven||831 661|
|Mcroberts BV||444 021|
|Norges teknisk-naturvitenskapelige universitet - NTNU||2 261 649|
|Penumologisches Forschungsinstitutan Der Lungenclinic Grosshansdorf GMBH||796 413|
|Robert Bosch Gesellschaft Fur Medizinische Forschung Mbh||2 495 296|
|The Foundation For Medical Research Infrastructural Development And Health Services Next To The Medical Center Tel Aviv||1 117 625|
|The University Of Sheffield||1 643 147|
|Universita Degli Studi Di Sassari||398 750|
|Universita Vita-Salute San Raffaele||704 105|
|Universitat Zurich||532 500|
|Universitatsklinikum Erlangen||1 125 055|
|University College Dublin, National University Of Ireland, Dublin||1 551 550|
|University Of Newcastle Upon Tyne||3 843 161|
|University Of Northumbria At Newcastle||432 261|
|Name||Funding in €|
|Sheffield Teaching Hospitals Nhs Foundation Trust||449 820|
|The Newcastle Upon Tyne Hospitals Nhs Foundation Trust||65 781|
|Total Cost||25 395 899|