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Specific barriers to the conduct of randomised clinical trials on medical devices

BACKGROUND: Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the...

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Detalles Bibliográficos
Autores principales:	Neugebauer, Edmund A. M., Rath, Ana, Antoine, Sunya-Lee, Eikermann, Michaela, Seidel, Doerthe, Koenen, Carsten, Jacobs, Esther, Pieper, Dawid, Laville, Martine, Pitel, Séverine, Martinho, Cecilia, Djurisic, Snezana, Demotes-Mainard, Jacques, Kubiak, Christine, Bertele, Vittorio, Jakobsen, Janus C., Garattini, Silvio, Gluud, Christian
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2017
Materias:	Review
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5597993/ https://www.ncbi.nlm.nih.gov/pubmed/28903769 http://dx.doi.org/10.1186/s13063-017-2168-0

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