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

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Since 2007, the European Union has mandated that newly authorized medicines for adults are tested in pediatric trials. In this study, Florence Bourgeois and colleagues evaluate the success of this regulation in terms of planned, completed and reported pediatric trials.

Vyšlo v časopise: Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study. PLoS Med 15(3): e32767. doi:10.1371/journal.pmed.1002520
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1002520

Souhrn

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