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Regulatory Qualification of a Cross-Disease Digital Measure: Benefits and Challenges from the Perspective of IMI Consortium IDEA-FAST

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 Ag...

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Detalles Bibliográficos
Autores principales: Nobbs, David, Piwko, Wojciech, Bull, Christopher, Cormack, Francesca, Ahmaniemi, Teemu, Holst, Sebastian C., Chatterjee, Meenakshi, Maetzler, Walter, Avey, Stefan, Ng, Wan Fai
Formato: Online Artículo Texto
Lenguaje:English
Publicado: S. Karger AG 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10601930/
https://www.ncbi.nlm.nih.gov/pubmed/37901363
http://dx.doi.org/10.1159/000533189