Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson’s Patients Using Digital Mobility Outcomes
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 fi...
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| Format: | Article |
| Language: | English |
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MDPI AG
2020-10-01
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| Series: | Sensors |
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| Online Access: | https://www.mdpi.com/1424-8220/20/20/5920 |
| _version_ | 1797550402134081536 |
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| author | Marco Viceconti Sabina Hernandez Penna Wilhelmus Dartee Claudia Mazzà Brian Caulfield Clemens Becker Walter Maetzler Judith Garcia-Aymerich Giorgio Davico Lynn Rochester |
| author_facet | Marco Viceconti Sabina Hernandez Penna Wilhelmus Dartee Claudia Mazzà Brian Caulfield Clemens Becker Walter Maetzler Judith Garcia-Aymerich Giorgio Davico Lynn Rochester |
| author_sort | Marco Viceconti |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-10T15:28:46Z |
| format | Article |
| id | doaj.art-97a8e425058e47628a608baabeccdf8b |
| institution | Directory Open Access Journal |
| issn | 1424-8220 |
| language | English |
| last_indexed | 2024-03-10T15:28:46Z |
| publishDate | 2020-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Sensors |
| spelling | doaj.art-97a8e425058e47628a608baabeccdf8b2023-11-20T17:48:36ZengMDPI AGSensors1424-82202020-10-012020592010.3390/s20205920Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson’s Patients Using Digital Mobility OutcomesMarco Viceconti0Sabina Hernandez Penna1Wilhelmus Dartee2Claudia Mazzà3Brian Caulfield4Clemens Becker5Walter Maetzler6Judith Garcia-Aymerich7Giorgio Davico8Lynn Rochester9Department of Industrial Engineering, Alma Mater Studiorum-University of Bologna, 40136 Bologna, ItalyRegulatory Affairs, Novartis Pharma AG, 4001 Basel, SwitzerlandRegulatory Affairs, Novartis Pharma AG, 4001 Basel, SwitzerlandDepartment of Mechanical Engineering and Insigneo Institute for in silico Medicine, University of Sheffield, Sheffield S10 2TN, UKSFI Insight Centre for Data Analytics, University College Dublin, 716 7777 Dublin, IrelandDepartment of Geriatric Medicine, Robert Bosch Gesellschaft für Medizinische Forschung mbH, 70376 Stuttgart, GermanyDepartment of Neurology, Christian-Albrechts-Universität zu Kiel, 24118 Kiel, GermanyBarcelona Institute for Global Health, 08003 Barcelona, SpainDepartment of Industrial Engineering, Alma Mater Studiorum-University of Bologna, 40136 Bologna, ItalyInstitute of Translational and Clinical Research, Newcastle University, Newcastle NE1 7RU, UKWearable 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.https://www.mdpi.com/1424-8220/20/20/5920inertial measurement unitmobility performanceregulatory science |
| spellingShingle | Marco Viceconti Sabina Hernandez Penna Wilhelmus Dartee Claudia Mazzà Brian Caulfield Clemens Becker Walter Maetzler Judith Garcia-Aymerich Giorgio Davico Lynn Rochester Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson’s Patients Using Digital Mobility Outcomes Sensors inertial measurement unit mobility performance regulatory science |
| title | Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson’s Patients Using Digital Mobility Outcomes |
| title_full | Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson’s Patients Using Digital Mobility Outcomes |
| title_fullStr | Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson’s Patients Using Digital Mobility Outcomes |
| title_full_unstemmed | Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson’s Patients Using Digital Mobility Outcomes |
| title_short | Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson’s Patients Using Digital Mobility Outcomes |
| title_sort | toward a regulatory qualification of real world mobility performance biomarkers in parkinson s patients using digital mobility outcomes |
| topic | inertial measurement unit mobility performance regulatory science |
| url | https://www.mdpi.com/1424-8220/20/20/5920 |
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