How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints

INTRODUCTION: Digital health technologies (DHTs) provide opportunities for real-time data collection and assessment of patient function. However, use of DHT-derived endpoints in clinical trials to support medical product labelling claims is limited. METHODS: From November 2020 through March 2021, th...

Descripción completa

Detalles Bibliográficos
Autores principales: Perry, Brian, Kehoe, Lindsay, Swezey, Teresa, Le Masne, Quentin, Goldhahn, Jörg, Staley, Alicia, Corneli, Amy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: S. Karger AG 2023
Materias:
Interview
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10315005/
https://www.ncbi.nlm.nih.gov/pubmed/37404865
http://dx.doi.org/10.1159/000529878

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10315005/
https://www.ncbi.nlm.nih.gov/pubmed/37404865
http://dx.doi.org/10.1159/000529878

Ejemplares similares