European survey on national harmonization in clinical research

Annette Magnin, Valentina Cabral Iversen, Gonzalo Calvo, Beata Čečetková, Ola Dale, Regina Demlová, György Blaskó, Fionnuala Keane, Gabor L. Kovacs, Claire Levy‐marchal, Emilia C. Monteiro, Lucia Palmisano, Daniel Pella, Antonio Portolés, Olivier Rascol, Caecilia Schmid, Fabian Tay, Heiko Leyen, Christian Ohmann

Research output: Contribution to journalArticle

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Abstract

Background: Clinical trials remain key to the development of evidence-based medical practice. However, they are becoming increasingly complex, mainly in a multinational setting. To address these challenges, the European Union (EU) adopted the Clinical Trial Regulation EU No. 536/2014 (CTR). Once in force, the CTR will lead to more consistent rules and simplification of procedures for conducting clinical trials through-out the EU. Existing harmonization initiatives and “research infrastructures” for clinical trials may facilitate this process. This publication offers a snapshot of the current level of harmonization activities in academic clinical research in Europe.
Methods: A survey was performed among the member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardized
Original languageEnglish
Pages (from-to)1-9
JournalLearning Health Systems
DOIs
Publication statusPublished - Jan 2020

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