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Perspective

Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson’s Patients Using Digital Mobility Outcomes

1
Department of Industrial Engineering, Alma Mater Studiorum-University of Bologna, 40136 Bologna, Italy
2
Medical Technology Lab, IRCCS Istituto Ortopedico Rizzoli, 40136 Bologna, Italy
3
Regulatory Affairs, Novartis Pharma AG, 4001 Basel, Switzerland
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Department of Mechanical Engineering and Insigneo Institute for in silico Medicine, University of Sheffield, Sheffield S10 2TN, UK
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SFI Insight Centre for Data Analytics, University College Dublin, 716 7777 Dublin, Ireland
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Department of Geriatric Medicine, Robert Bosch Gesellschaft für Medizinische Forschung mbH, 70376 Stuttgart, Germany
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Department of Neurology, Christian-Albrechts-Universität zu Kiel, 24118 Kiel, Germany
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Barcelona Institute for Global Health, 08003 Barcelona, Spain
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Departament de Ciències Experimentals i de la Salut, Universitat Pompeu Fabra (UPF), 08002 Barcelona, Spain
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CIBER Epidemiología y Salud Pública (CIBERESP), 28029 Madrid, Spain
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Institute of Translational and Clinical Research, Newcastle University, Newcastle NE1 7RU, UK
*
Author to whom correspondence should be addressed.
Sensors 2020, 20(20), 5920; https://doi.org/10.3390/s20205920
Received: 7 September 2020 / Revised: 12 October 2020 / Accepted: 17 October 2020 / Published: 20 October 2020
(This article belongs to the Special Issue Sensors in Biomechanics)
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. View Full-Text
Keywords: inertial measurement unit; mobility performance; regulatory science inertial measurement unit; mobility performance; regulatory science
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MDPI and ACS Style

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 2020, 20, 5920. https://doi.org/10.3390/s20205920

AMA Style

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. 2020; 20(20):5920. https://doi.org/10.3390/s20205920

Chicago/Turabian Style

Viceconti, Marco, Sabina Hernandez Penna, Wilhelmus Dartee, Claudia Mazzà, Brian Caulfield, Clemens Becker, Walter Maetzler, Judith Garcia-Aymerich, Giorgio Davico, and Lynn Rochester. 2020. "Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson’s Patients Using Digital Mobility Outcomes" Sensors 20, no. 20: 5920. https://doi.org/10.3390/s20205920

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