Viceconti, MarcoHernández Penna, SabinaDartee, WilhelmusMazzà, ClaudiaCaulfield, BrianBecker, ClemensMaetzler, WalterGarcía Aymerich, JudithDavico, GiorgioRochester, Lynn2021-01-252021-01-252020Viceconti 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/s202059201424-8220http://hdl.handle.net/10230/46258Wearable 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.application/pdfeng© 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/).info:eu-repo/semantics/articlehttp://dx.doi.org/10.3390/s20205920Inertial measurement unitMobility performanceRegulatory scienceinfo:eu-repo/semantics/openAccess