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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...
Autores principales: | 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. |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Berlin Heidelberg
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7351802/ https://www.ncbi.nlm.nih.gov/pubmed/32535715 http://dx.doi.org/10.1007/s00431-020-03715-3 |
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