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Beyond the RCT: When are Randomized Trials Unnecessary for New Therapeutic Devices, and What Should We Do Instead?

The aim of this study was to develop an evidence-based framework for evaluation of therapeutic devices, based on ethical principles and clinical evidence considerations SUMMARY BACKGROUND DATA: Nearly all medical products which do not work solely through chemical action are regulated as medical devi...

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Detalles Bibliográficos
Autores principales: Páez, Arsenio, Rovers, Maroeska, Hutchison, Katrina, Rogers, Wendy, Vasey, Baptiste, McCulloch, Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8746919/
https://www.ncbi.nlm.nih.gov/pubmed/34238815
http://dx.doi.org/10.1097/SLA.0000000000005053