Evidentiary basis of the first regulatory qualification of a digital primary efficacy endpoint

Abstract Stride velocity 95th centile (SV95C) is a wearable-derived endpoint representing the 5% fastest strides taken during everyday living. In July 2023, SV95C received European Medicines Agency (EMA) qualification for use as a primary endpoint in trials of patients with Duchenne muscular dystrop...

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Principais autores:	Laurent Servais, Paul Strijbos, Margaux Poleur, Andrada Mirea, Nina Butoianu, Valeria A. Sansone, Carole Vuillerot, Ulrike Schara-Schmidt, Mariacristina Scoto, Andreea M. Seferian, Stefano C. Previtali, Már Tulinius, Andrés Nascimento, Pat Furlong, Teji Singh, Roxana Donisa Dreghici, Nathalie Goemans, Eugenio Mercuri, Volker Straub, Maitea Guridi Ormazabal, Jessica Braid, Francesco Muntoni, Alexis Tricot, Mélanie Annoussamy, Damien Eggenspieler
Formato:	Artigo
Idioma:	Inglês
Publicado:	Nature Portfolio 2024-11-01
Series:	Scientific Reports
Assuntos:	Stride Velocity 95th Centile Digital endpoints Wearables Duchenne muscular dystrophy Regulatory qualification V3 framework
Acceso en liña:	https://doi.org/10.1038/s41598-024-80177-9
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