Summary
The way we move is an indication of how healthy we are. Declines in mobility are linked to the progression of Parkinson’s disease, multiple sclerosis, congestive heart failure and chronic obstructive pulmonary disease (COPD) and can indicate that proximal femur fractures, a type of hip fracture commonly seen in older patients, have occurred. Traditionally, clinicians have tested people’s capacity to move in spot tests at a clinic, but this only provides a snapshot of a person’s health – typically a clinician might see a patient for one 15-minute slot out of an entire year. Mobilise-D set out to develop digital mobility outcomes that can be used by clinicians to evaluate how a person’s disease may be progressing.
Mobilise-D’s system involves using a single device attached to a patient’s back and measuring how a person walks as they go about their everyday activities over the course of several days. Algorithms developed by the project then translate the device readings into digital mobility outcomes that can indicate a change in a person’s disease status, how it is evolving over time and even predict future health events. Twenty-four digital mobility outcomes have been clinically validated as part of the project.
If you are a patient with Parkinson’s or COPD, a clinician may decide that the best way to monitor how well your medication is working is to send you home with a sensor attached to your back using a special waterproof patch made by the project, and evaluate your gait against Mobilise-D’s 24 digital mobility outcomes over the course of a week. This system gives clinicians and researchers access to more accurate, real-world data about the patient’s mobility and represents a big leap forward for monitoring and measuring a person’s walking pattern and gait in clinical trials.
A trusted device-algorithm combination
A key step for Mobilise-D was to technically validate the device and the algorithms that would be used to detect changes in mobility. A multicomponent algorithm was developed to see whether, when combined with a wearable device with the correct technical characteristics, it could accurately detect movement changes.
First, the team compared their device to ten other sensors found in the literature, to check that they were using the highest quality product. Then, the algorithms’ performance was evaluated in laboratory settings, at five different clinical sites. In the laboratories, patients simulated the daily activities that they would normally undertake at home.
Outside of the lab, the project compared the results of the Mobilise-D algorithms to those obtained by the INDIP system – a multi-sensor system that is the current gold standard for outside-the-lab mobility tests. What they found was that Mobilise-D’s one-sensor system gave similar results – and it is a system that is much easier for and better tolerated by patients.
The next step was clinical validation, where a device’s accuracy is tested to meet clinical standards. Clinical validation studies were carried out for four different conditions: multiple sclerosis, chronic obstructive pulmonary disease, Parkinson’s disease and hip fractures. The goal was to link the digital mobility outcomes (DMOs) to clinical endpoints. DMOs were tested as predictors of mobility, disability, falls, hospitalisation, nursing home admission, and mortality. A clinical assessment protocol was refined for each disease cohort and the clinical validity of DMOs to predict clinical endpoints was established.
Digital health solutions leading towards at-home clinical trials
Mobilise-D’s results are timely, as in the wake of the COVID-19 pandemic clinical studies are increasingly turning towards decentralisation. Monitoring patients at home can paint a more accurate picture of how interventions are working for them in their day-to-day lives and clinical studies can also incorporate data from hard-to-reach patient populations if it is possible for patients to take part in trials or interventions.
Accessible code leading to commercial take-up
The results of Mobilise-D were promising, but had been developed using a closed code system. To make it easy for clinical researchers to use Mobilise-D’s algorithms in their studies, the algorithms were translated into a common computer language – Python – and uploaded to an open source platform – GitHub. Ensuring that the code could be used by others was paramount to securing its uptake. The code can be accessed here.
To date, four companies have integrated Mobilise-D’s algorithms into their products and services. EMPATICA, a company that provides health monitoring services for research purposes, is now using Mobilise-D’s algorithms in their Health Monitoring Platform. Clario, McRoberts and Actigraph have also incorporated the project’s results into their offerings.
Regulatory support and synergies with other IMI projects
The consortium has also received two letters of support from the European Medicines’ Agency and has submitted a pre-Letter of Intent to the US Food and Drug Administration on using digital mobility outcomes for multiple sclerosis. Both agencies identified the appropriateness of the methodology used in the Mobilise-D approach but also the need for clinical trial data for any future qualification opinion.
The Mobilise-D Network was set up to advance digital mobility assessments, continuing the impact of the Mobilise-D project. The network aims to facilitate collaboration between industry and academia, introduce and nurture new researchers in the field and build a network consisting of a diverse range of stakeholders, including researchers, healthcare professionals, industry leaders, policymakers, regulators, patients and patient advocates. This community will serve to foster connections and boost innovation in this field.
The road forwards
Mobilise-D will continue to advance its achievements in the future, including managing the sharing of the algorithms and data from both the technical and clinical validation studies as well as promoting the use of the Moblise-D digital mobility outcomes. An important resource for researchers will be the data from the clinical validation study, which will start to be released by the end of 2025. Additional funding has been provided by a number of the EFPIA partners within the Mobilise-D project which will fund a range of work to maximise impact and create a sustainable future for the technology and knowledge generated within Mobilise-D.
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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.
Find out more
- Read the article in full
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.
Find out more
- Visit the IDEA-FAST website
- Visit the Mobilise-D website
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.
Find out more
- Read the article in full
- Join in the discussions on Mobilise-D’s Slack channel #dHealth4Trials
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.
Find out more
- To join the discussion, fill in the form at www.insilico.world/digitaltechnologies/
- Visit the In Silico World website
- Visit the Mobilise-D website
Participants
Show participants on mapEFPIA companies
- Amgen Limited, Cambridge, United Kingdom
- Astrazeneca AB, Sodertaelje, 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, United Kingdom
- Sanofi-Aventis Recherche & Developpement, Gentilly, France
- Takeda Development Centre Europe LTD, London, United Kingdom
- Teva Pharmaceutical Industries Limited, Petach Tivka, 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 Vita-Salute San Raffaele, Milano, Italy
- Universitat Zurich, Zurich, 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, Twickenham Middlesex, United Kingdom
- Mcroberts BV, 's-Gravenhage (Den Haag), Netherlands
- Universita Degli Studi Di Sassari, Sassari, Italy
- Velocity Clinical Research Grosshansdorf GMBH, Grosshansdorf, Germany
Third parties
- Sheffield Teaching Hospitals Nhs Foundation Trust, Sheffield, United Kingdom
- The Newcastle Upon Tyne Hospitals Nhs Foundation Trust, Newcastle-Upon-Tyne, United Kingdom
| Participants | |
|---|---|
| Name | EU funding in € |
| Alma Mater Studiorum - Universita Di Bologna | 855 665 |
| Centre Hospitalier Universitaire Montpellier | 514 685 |
| Christian-Albrechts-Universitaet Zu Kiel | 973 944 |
| Ecole Polytechnique Federale De Lausanne | 993 625 |
| Friedrich-Alexander-Universitaet Erlangen-Nuernberg | 847 864 |
| Fundacion Privada Instituto De Salud Global Barcelona | 1 597 781 |
| Imperial College Of Science Technology And Medicine | 392 415 |
| Ixscient Limited | 464 000 |
| Katholieke Universiteit Leuven | 833 536 |
| Mcroberts BV | 592 188 |
| Norges teknisk-naturvitenskapelige universitet - NTNU | 2 163 524 |
| Robert Bosch Gesellschaft Fur Medizinische Forschung Mbh | 2 647 171 |
| The Foundation For Medical Research Infrastructural Development And Health Services Next To The Medical Center Tel Aviv | 1 117 625 |
| The University Of Sheffield | 1 334 953 |
| Universita Degli Studi Di Sassari | 391 250 |
| Universita Vita-Salute San Raffaele | 705 980 |
| Universitat Zurich | 511 875 |
| Universitatsklinikum Erlangen | 1 126 930 |
| University College Dublin, National University Of Ireland, Dublin | 1 484 050 |
| University Of Newcastle Upon Tyne | 3 737 460 |
| University Of Northumbria At Newcastle | 434 136 |
| Velocity Clinical Research Grosshansdorf GMBH | 796 413 |
| Third parties | |
| Name | Funding in € |
| Sheffield Teaching Hospitals Nhs Foundation Trust | 759 888 |
| The Newcastle Upon Tyne Hospitals Nhs Foundation Trust | 118 940 |
| Total Cost | 25 395 898 |
Ronenn Roubenoff
Novartis Pharma AG
Lynn Rochester
University Of Newcastle Upon Tyne