Toward a regulatory qualification of real-world mobility performance biomarkers in parkinson's patients using digital mobility outcomes
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- dc.contributor.author Viceconti, Marco
- dc.contributor.author Hernández Penna, Sabina
- dc.contributor.author Dartee, Wilhelmus
- dc.contributor.author Mazzà, Claudia
- dc.contributor.author Caulfield, Brian
- dc.contributor.author Becker, Clemens
- dc.contributor.author Maetzler, Walter
- dc.contributor.author García Aymerich, Judith
- dc.contributor.author Davico, Giorgio
- dc.contributor.author Rochester, Lynn
- dc.date.accessioned 2021-01-25T07:30:52Z
- dc.date.available 2021-01-25T07:30:52Z
- dc.date.issued 2020
- dc.description.abstract 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's 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.
- dc.description.sponsorship This study was supported by the project Mobilise-D, “Digital sensors to monitor mobility, disease progression”, Grant agreement ID: 820820, funded by the European Commission through the programme H2020-EU.3.1.7.-Innovative Medicines Initiative 2 (IMI2). Author JGA also acknowledge support from the Spanish Ministry of Science and Innovation through the “Centro de Excelencia Severo Ochoa 2019–2023” Program (CEX2018-000806-S), and support from the Generalitat de Catalunya through the CERCA Program.
- dc.format.mimetype application/pdf
- dc.identifier.citation Viceconti M, Hernandez Penna S, Dartee W, Mazzà C, Caulfield B, Becker C, Maetzler W, Garcia-Aymerich J, Davico G, Rochester L. Toward a regulatory qualification of real-world mobility performance biomarkers in parkinson's patients using digital mobility outcomes. Sensors (Basel). 2020; 20(20):5920. DOI: 10.3390/s20205920
- dc.identifier.doi http://dx.doi.org/10.3390/s20205920
- dc.identifier.issn 1424-8220
- dc.identifier.uri http://hdl.handle.net/10230/46258
- dc.language.iso eng
- dc.publisher MDPI
- dc.relation.ispartof Sensors (Basel). 2020; 20(20):5920
- dc.relation.projectID info:eu-repo/grantAgreement/EC/H2020/820820
- dc.rights © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
- dc.rights.accessRights info:eu-repo/semantics/openAccess
- dc.rights.uri http://creativecommons.org/licenses/by/4.0/
- dc.subject.keyword Inertial measurement unit
- dc.subject.keyword Mobility performance
- dc.subject.keyword Regulatory science
- dc.title Toward a regulatory qualification of real-world mobility performance biomarkers in parkinson's patients using digital mobility outcomes
- dc.type info:eu-repo/semantics/article
- dc.type.version info:eu-repo/semantics/publishedVersion