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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?

Autor: Max Knaapen, Maya Kruijt, Martine Corrette Ploem, Rieke van der Graaf, Johanna H. van der Lee, Roel Bakx, Martijn A. Oudijk, Pierre M. Bet, L. W. Ernst van Heurn, Ramon R. Gorter

Publikováno v: European Journal of Pediatrics
Knaapen, M, Ploem, M C, Kruijt, M, Oudijk, M A, van der Graaf, R, Bet, P M, Bakx, R, van Heurn, L W E, Gorter, R R & van der Lee, J H 2020, ' Low-risk trials for children and pregnant women threatened by unnecessary strict regulations. Does the coming EU Clinical Trial Regulation offer a solution? ', European Journal of Pediatrics, vol. 179, no. 8, pp. 1205-1211 . https://doi.org/10.1007/s00431-020-03715-3

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 E

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::73ba9e1fa85d6fc8688c0d398c7affd2
https://doi.org/10.1007/s00431-020-03715-3

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[Medical-ethical review of multicenter studies can be obtained faster: new directive leaves room for improvement]

Autor: Katrien, Oude Rengerink, Maya, Kruijt, Ben Willem, Mol

Publikováno v: Nederlands tijdschrift voor geneeskunde. 157(42)

To evaluate whether the speed at which multicenter studies can be launched in the Netherlands has been improved by the new External Review Directive.Cohort study.We studied the time between requesting and granting a declaration of local feasibility o

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::3f16198f307988ec97ce04df80e47475
https://pubmed.ncbi.nlm.nih.gov/24128596

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