Stride Velocity 95th Centile: Insights into Gaining Regulatory Qualification of the First Wearable-Derived Digital Endpoint for use in Duchenne Muscular Dystrophy Trials

In 2019, stride velocity 95th centile (SV95C) became the first wearable-derived digital clinical outcome assessment (COA) qualified by the European Medicines Agency (EMA) for use as a secondary endpoint in trials for Duchenne muscular dystrophy. SV95C was approved via the EMA’s qualification pathway...

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Detalles Bibliográficos
Autores principales: Servais, Laurent, Yen, Karl, Guridi, Maitea, Lukawy, Jacek, Vissière, David, Strijbos, Paul
Formato: Online Artículo Texto
Lenguaje:English
Publicado: IOS Press 2022
Materias:
Commentary
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9028650/
https://www.ncbi.nlm.nih.gov/pubmed/34958044
http://dx.doi.org/10.3233/JND-210743

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