On the use of wearable sensors as mobility biomarkers in the marketing authorization of new drugs: A regulatory perspective

Viceconti, Marco; Tome, Maria; Dartee, Wilhelmus; Knezevic, Igor; Hernandez Penna, Sabina; Mazzà, Claudia; Caulfield, Brian; García Aymerich, Judith; Becker, Clemens; Maetzler, Walter; Troosters, Thierry; Sharrack, Basil; Davico, Giorgio; Corriol-Rohou, Solange; Rochester, Lynn; Mobilise-D consortium

On the use of wearable sensors as mobility biomarkers in the marketing authorization of new drugs: A regulatory perspective

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dc.contributor.author Viceconti, Marco
dc.contributor.author Tome, Maria
dc.contributor.author Dartee, Wilhelmus
dc.contributor.author Knezevic, Igor
dc.contributor.author Hernandez Penna, Sabina
dc.contributor.author Mazzà, Claudia
dc.contributor.author Caulfield, Brian
dc.contributor.author García Aymerich, Judith
dc.contributor.author Becker, Clemens
dc.contributor.author Maetzler, Walter
dc.contributor.author Troosters, Thierry
dc.contributor.author Sharrack, Basil
dc.contributor.author Davico, Giorgio
dc.contributor.author Corriol-Rohou, Solange
dc.contributor.author Rochester, Lynn
dc.contributor.author Mobilise-D consortium
dc.date.accessioned 2023-11-08T07:38:19Z
dc.date.available 2023-11-08T07:38:19Z
dc.date.issued 2022
dc.description.abstract The loss of mobility is a common trait in multiple health conditions (e.g., Parkinson's disease) and is associated with reduced quality of life. In this context, being able to monitor mobility in the real world, is important. Until recently, the technology was not mature enough for this; but today, miniaturized sensors and novel algorithms promise to monitor mobility accurately and continuously in the real world, also in pathological populations. However, before any such methodology can be employed to support the development and testing of new drugs in clinical trials, they need to be qualified by the competent regulatory agencies (e.g., European Medicines Agency). Nonetheless, to date, only very narrow scoped requests for regulatory qualification were successful. In this work, the Mobilise-D Consortium shares its positive experience with the European regulator, summarizing the two requests for Qualification Advice for the Mobilise-D methodologies submitted in October 2019 and June 2020, as well as the feedback received, which resulted in two Letters of Support publicly available for consultation on the website of the European Medicines Agency. Leveraging on this experience, we hereby propose a refined qualification strategy for the use of digital mobility outcome (DMO) measures as monitoring biomarkers for mobility in drug trials.
dc.description.sponsorship This work was supported by the Mobilise-D project that has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No. 820820. This JU receives support from the European Union's Horizon 2020 research and innovation program and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Content in this publication reflects the authors' view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein. CM was supported by the NIHR Sheffield Biomedical Research Center (BRC).
dc.format.mimetype application/pdf
dc.identifier.citation Viceconti M, Tome M, Dartee W, Knezevic I, Hernandez Penna S, Mazzà C, Caulfield B, Garcia-Aymerich J, Becker C, Maetzler W, Troosters T, Sharrack B, Davico G, Corriol-Rohou S, Rochester L; Mobilise-D Consortium. On the use of wearable sensors as mobility biomarkers in the marketing authorization of new drugs: A regulatory perspective. Front Med (Lausanne). 2022 Sep 21;9:996903. DOI: 10.3389/fmed.2022.996903
dc.identifier.doi http://dx.doi.org/10.3389/fmed.2022.996903
dc.identifier.issn 2296-858X
dc.identifier.uri http://hdl.handle.net/10230/58230
dc.language.iso eng
dc.publisher Frontiers
dc.relation.ispartof Front Med (Lausanne). 2022 Sep 21;9:996903
dc.relation.projectID info:eu-repo/grantAgreement/EC/H2020/820820
dc.rights © 2022 Viceconti, Tome, Dartee, Knezevic, Hernandez Penna, Mazzà, Caulfield, Garcia-Aymerich, Becker, Maetzler, Troosters, Sharrack, Davico, Corriol-Rohou, Rochester and the Mobilise-D Consortium. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) (http://creativecommons.org/licenses/by/4.0/). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.rights.uri http://creativecommons.org/licenses/by/4.0/
dc.subject.keyword Digital mobility outcomes
dc.subject.keyword Mobility biomarkers
dc.subject.keyword Mobility disability
dc.subject.keyword Regulatory qualification
dc.subject.keyword Wearable sensors
dc.title On the use of wearable sensors as mobility biomarkers in the marketing authorization of new drugs: A regulatory perspective
dc.type info:eu-repo/semantics/article
dc.type.version info:eu-repo/semantics/publishedVersion

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