Dartee, Wim and Hernandez Penna, Sabina (2022) ON THE USE OF WEARABLE SENSORS AS MOBILITY BIOMARKERS IN THE MARKETING AUTHORISATION OF NEW DRUGS: A REGULATORY PERSPECTIVE. Frontiers in Medicine.

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, miniaturised 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, summarising 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.

Item Type:	Article
Date Deposited:	05 Oct 2022 00:46
Last Modified:	05 Oct 2022 00:46
URI:	https://oak.novartis.com/id/eprint/46539