PERSPECTIVE article
Front. Med. Technol.
Sec. Regulatory Affairs
Volume 7 - 2025 | doi: 10.3389/fmedt.2025.1567537
A hybrid, iterative approach to support development of fit-forpurpose sensor-derived measures
Provisionally accepted
- 1IQVIA (Spain), Barcelona, Spain
- 2IQVIA (United Kingdom), London, United Kingdom
- 3IQVIA Inc, North Carolina, United States
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Digital Health Technologies (DHTs) hold immense potential for transforming drug development. Although innovation in the DHT space has been rapid, the approval process for these technologies remains slow due to fragmented efforts from industry and researchers, as well as regulatory challenges. In this position paper, we propose a hybrid methodology and approach for developing fit-for-purpose DHTs for assessment by integrating both patient-centric and datacentric elements. By emphasizing patient relevance while considering device and data feasibility, we can advance the development of patient-centric digital measures efficiently without compromising measurement precision. Ultimately, this hybrid approach aims to streamline the approval process, foster collaboration among stakeholders, and accelerate the integration of DHTs into clinical practice, thereby enhancing the overall efficiency and effectiveness of drug development.
Keywords: #digital measures, #fit-for-purpose DHTs, #sensor-derived COAs, #DHT, #patient-centricity
Received: 06 Feb 2025; Accepted: 29 Aug 2025.
Copyright: © 2025 Rubio Ballester, Reaney, Mack and Ajraoui. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor 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.
* Correspondence: Salma Ajraoui, IQVIA (United Kingdom), London, United Kingdom
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.