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

Marco Viceconti, Sabina Hernandez Penna, Wilhelmus Dartee, Claudia Mazzà, Brian Caulfield, Clemens Becker, Walter Maetzler, Judith Garcia-Aymerich, Giorgio Davico, Lynn Rochester

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Article number5920
Pages (from-to)1-13
Number of pages13
JournalSensors (Switzerland)
Volume20
Issue number20
DOIs
Publication statusPublished - Oct 2 2020

Keywords

  • Inertial measurement unit
  • Mobility performance
  • Regulatory science

ASJC Scopus subject areas

  • Analytical Chemistry
  • Biochemistry
  • Atomic and Molecular Physics, and Optics
  • Instrumentation
  • Electrical and Electronic Engineering

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