Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study

BACKGROUND: Few medicines have been approved for children, leading to rates of off-label prescribing reported to be as high as 90%. In 2007, the European Union adopted the Paediatric Regulation, which mandates that pharmaceutical companies conduct paediatric studies for all new medicines, unless gra...

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Detalles Bibliográficos
Autores principales: Hwang, Thomas J., Tomasi, Paolo A., Bourgeois, Florence T.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2018
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5832187/
https://www.ncbi.nlm.nih.gov/pubmed/29494592
http://dx.doi.org/10.1371/journal.pmed.1002520

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