{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T08:36:19Z","timestamp":1773131779573,"version":"3.50.1"},"reference-count":60,"publisher":"MDPI AG","issue":"20","license":[{"start":{"date-parts":[[2020,10,20]],"date-time":"2020-10-20T00:00:00Z","timestamp":1603152000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Sensors"],"abstract":"<jats:p>Wearable inertial sensors can be used to monitor mobility in real-world settings over extended periods. Although these technologies are widely used in human movement research, they have not yet been qualified by drug regulatory agencies for their use in regulatory drug trials. This is because the first generation of these sensors was unreliable when used on slow-walking subjects. However, intense research in this area is now offering a new generation of algorithms to quantify Digital Mobility Outcomes so accurate they may be considered as biomarkers in regulatory drug trials. This perspective paper summarises the work in the Mobilise-D consortium around the regulatory qualification of the use of wearable sensors to quantify real-world mobility performance in patients affected by Parkinson\u2019s Disease. The paper describes the qualification strategy and both the technical and clinical validation plans, which have recently received highly supportive qualification advice from the European Medicines Agency. The scope is to provide detailed guidance for the preparation of similar qualification submissions to broaden the use of real-world mobility assessment in regulatory drug trials.<\/jats:p>","DOI":"10.3390\/s20205920","type":"journal-article","created":{"date-parts":[[2020,10,20]],"date-time":"2020-10-20T09:28:23Z","timestamp":1603186103000},"page":"5920","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":49,"title":["Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson\u2019s Patients Using Digital Mobility Outcomes"],"prefix":"10.3390","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2293-1530","authenticated-orcid":false,"given":"Marco","family":"Viceconti","sequence":"first","affiliation":[{"name":"Department of Industrial Engineering, Alma Mater Studiorum-University of Bologna, 40136 Bologna, Italy"},{"name":"Medical Technology Lab, IRCCS Istituto Ortopedico Rizzoli, 40136 Bologna, Italy"}]},{"given":"Sabina","family":"Hernandez Penna","sequence":"additional","affiliation":[{"name":"Regulatory Affairs, Novartis Pharma AG, 4001 Basel, Switzerland"}]},{"given":"Wilhelmus","family":"Dartee","sequence":"additional","affiliation":[{"name":"Regulatory Affairs, Novartis Pharma AG, 4001 Basel, Switzerland"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5215-1746","authenticated-orcid":false,"given":"Claudia","family":"Mazz\u00e0","sequence":"additional","affiliation":[{"name":"Department of Mechanical Engineering and Insigneo Institute for in silico Medicine, University of Sheffield, Sheffield S10 2TN, UK"}]},{"given":"Brian","family":"Caulfield","sequence":"additional","affiliation":[{"name":"SFI Insight Centre for Data Analytics, University College Dublin, 716 7777 Dublin, Ireland"}]},{"given":"Clemens","family":"Becker","sequence":"additional","affiliation":[{"name":"Department of Geriatric Medicine, Robert Bosch Gesellschaft f\u00fcr Medizinische Forschung mbH, 70376 Stuttgart, Germany"}]},{"given":"Walter","family":"Maetzler","sequence":"additional","affiliation":[{"name":"Department of Neurology, Christian-Albrechts-Universit\u00e4t zu Kiel, 24118 Kiel, Germany"}]},{"given":"Judith","family":"Garcia-Aymerich","sequence":"additional","affiliation":[{"name":"Barcelona Institute for Global Health, 08003 Barcelona, Spain"},{"name":"Departament de Ci\u00e8ncies Experimentals i de la Salut, Universitat Pompeu Fabra (UPF), 08002 Barcelona, Spain"},{"name":"CIBER Epidemiolog\u00eda y Salud P\u00fablica (CIBERESP), 28029 Madrid, Spain"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2046-529X","authenticated-orcid":false,"given":"Giorgio","family":"Davico","sequence":"additional","affiliation":[{"name":"Department of Industrial Engineering, Alma Mater Studiorum-University of Bologna, 40136 Bologna, Italy"},{"name":"Medical Technology Lab, IRCCS Istituto Ortopedico Rizzoli, 40136 Bologna, Italy"}]},{"given":"Lynn","family":"Rochester","sequence":"additional","affiliation":[{"name":"Institute of Translational and Clinical Research, Newcastle University, Newcastle NE1 7RU, UK"}]}],"member":"1968","published-online":{"date-parts":[[2020,10,20]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1","DOI":"10.14802\/jmd.16062","article-title":"Functional Neuroanatomy for Posture and Gait Control","volume":"10","author":"Takakusaki","year":"2017","journal-title":"J. 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