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Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports

Objective To investigate characteristics of clinical trials and results on safety and effectiveness reported in US Food and Drug Administration (FDA) documents for recently approved high risk cardiovascular devices compared with the characteristics and results reported in peer reviewed publications....

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Detalles Bibliográficos
Autores principales: Chang, Lee, Dhruva, Sanket S, Chu, Janet, Bero, Lisa A, Redberg, Rita F
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4462712/
https://www.ncbi.nlm.nih.gov/pubmed/26063311
http://dx.doi.org/10.1136/bmj.h2613