Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project

BACKGROUND: We describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512). This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European an...

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Detalhes bibliográficos
Publicado no:BMC Med Ethics
Main Authors: Giannuzzi, Viviana, Felisi, Mariagrazia, Bonifazi, Donato, Devlieger, Hugo, Papanikolaou, George, Ragab, Lamis, Fattoum, Slaheddine, Tempesta, Bianca, Reggiardo, Giorgio, Ceci, Adriana
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2021
Assuntos:
Research
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC8086274/
https://ncbi.nlm.nih.gov/pubmed/33926431
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s12910-021-00618-2
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