Low-risk trials for children and pregnant women threatened by unnecessary strict regulations. Does the coming EU Clinical Trial Regulation offer a solution?

Investigator-initiated clinical trials are crucial for improving quality of care for children and pregnant women as they are often excluded from industry-initiated trials. However, trials have become increasingly time-consuming and costly since the EU Clinical Trial Directive entered into force in 2...

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Detalhes bibliográficos
Publicado no:Eur J Pediatr
Main Authors: Knaapen, Max, Ploem, Martine Corrette, Kruijt, Maya, Oudijk, Martijn A., van der Graaf, Rieke, Bet, Pierre M., Bakx, Roel, van Heurn, L. W. Ernst, Gorter, Ramon R., van der Lee, Johanna H.
Formato: Artigo
Idioma:Inglês
Publicado em: Springer Berlin Heidelberg 2020
Assuntos:
Review
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7351802/
https://ncbi.nlm.nih.gov/pubmed/32535715
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s00431-020-03715-3
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