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Lookup NU author(s): Dr Christopher BullORCiD
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Background: Innovative Medicines Initiative (IMI) consortium IDEA-FAST is developing novel digital measures of fatigue, sleep quality, and impact of sleep disturbances for neurodegenerative diseases and immune-mediated inflammatory diseases. In 2022, the consortium met with the European Medicines Agency (EMA) to receive advice on its plans for regulatory qualification of the measures. This viewpoint reviews the IDEA-FAST perspective on developing digital measures for multiple diseases and the advice provided by the EMA. Summary: The EMA considered a cross-disease measure an interesting and arguably feasible concept. Developers should account for the need for a strong rationale that the clinical features to be measured are similar across diseases. In addition, they may expect increased complexity of study design, challenges when managing differences within and between disease populations, and the need for validation in both heterogeneous and homogeneous populations. Key Messages: EMA highlighted the challenges teams may encounter when developing a cross-disease measure, though benefits potentially include reduced resources for the technology developer and health authority, faster access to innovation across different therapeutic fields, and feasibility of cross-disease comparisons. The insights included here can be used by project teams to guide them in the development of cross-disease digital measures intended for regulatory qualification.
Author(s): Nobbs D, Piwko W, Bull C, Cormack F, Ahmaniemi T, Holst SC, Chatterjee M, Maetzler W, Avey S, Ng WF, IDEA-FAST C
Publication type: Article
Publication status: Published
Journal: Digital Biomarkers
Year: 2023
Volume: 7
Issue: 1
Pages: 132–138
Online publication date: 19/09/2023
Acceptance date: 11/07/2023
Date deposited: 22/11/2023
ISSN (electronic): 2504-110X
Publisher: Karger
URL: https://doi.org/10.1159/000533189
DOI: 10.1159/000533189
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