Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement


Start Date
End Date
IMI2 - Call 13
Grant agreement number

Type of Action: 
RIA (Research and Innovation Action)

IMI Funding
25 395 897
EFPIA in kind
23 965 667
Total Cost
49 361 564


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

Interested in the regulatory aspects of digital health? Join the new #dHealth4Trials Slack channel
September 2020

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

Participants Show participants on map

EFPIA companies
  • Amgen Limited, Cambridge, United Kingdom
  • 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
Third parties
  • Sheffield Teaching Hospitals Nhs Foundation Trust, Sheffield, United Kingdom
  • The Newcastle Upon Tyne Hospitals Nhs Foundation Trust, Newcastle-Upon-Tyne, United Kingdom
Project coordinator
Lynn Rochester
University Of Newcastle Upon Tyne