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...
Main Authors: | Viviana Giannuzzi, Mariagrazia Felisi, Donato Bonifazi, Hugo Devlieger, George Papanikolaou, Lamis Ragab, Slaheddine Fattoum, Bianca Tempesta, Giorgio Reggiardo, Adriana Ceci |
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Format: | Article |
Language: | English |
Published: |
BMC
2021-04-01
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Series: | BMC Medical Ethics |
Subjects: | |
Online Access: | https://doi.org/10.1186/s12910-021-00618-2 |
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