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Toward a regulatory qualification of real-world mobility performance biomarkers in parkinson’s patients using digital mobility outcomes

Lookup NU author(s): Professor Lynn RochesterORCiD

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).

Abstract

© 2020 by the authors.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.

Publication metadata

Author(s): Viceconti M, Penna SH, Dartee W, Mazza C, Caulfield B, Becker C, Maetzler W, Garcia-Aymerich J, Davico G, Rochester L

Publication type: Article

Publication status: Published

Journal: Sensors

Year: 2020

Volume: 20

Issue: 20

Pages: 1-13

Online publication date: 20/10/2020

Acceptance date: 17/10/2020

Date deposited: 09/11/2020

ISSN (electronic): 1424-8220

Publisher: MDPI AG

URL: https://doi.org/10.3390/s20205920

DOI: 10.3390/s20205920

PubMed id: 33092143

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