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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...
Autores principales: | Páez, Arsenio, Rovers, Maroeska, Hutchison, Katrina, Rogers, Wendy, Vasey, Baptiste, McCulloch, Peter |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2022
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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 |
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