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

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

Abstract 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 Eur...

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Bibliographic Details
Main Authors: Viviana Giannuzzi, Mariagrazia Felisi, Donato Bonifazi, Hugo Devlieger, George Papanikolaou, Lamis Ragab, Slaheddine Fattoum, Bianca Tempesta, Giorgio Reggiardo, Adriana Ceci
Format: Article
Language:English
Published: BMC 2021-04-01
Series:BMC Medical Ethics
Subjects:
Clinical trial application; Multi-national trial; Paediatric clinical research; Biomedical ethics
Online Access:https://doi.org/10.1186/s12910-021-00618-2

Internet

https://doi.org/10.1186/s12910-021-00618-2

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