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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主要な著者:	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
フォーマット:	Artigo
言語:	Inglês
出版事項:	Nature Portfolio 2024-11-01
シリーズ:	Scientific Reports
主題:	Stride Velocity 95th Centile Digital endpoints Wearables Duchenne muscular dystrophy Regulatory qualification V3 framework
オンライン･アクセス:	https://doi.org/10.1038/s41598-024-80177-9
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