Division and discord in the Clinical Trials Regulation

David Shaw*, David Townend

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


The Clinical Trials Regulation is intended to harmonise and streamline the review and conduct of clinical trials in the European Union. In this paper, we identify and analyse several serious issues concerning the division imposed by the Regulation between scientific review and ethical review. We conclude that these problems may compromise the objectives of the Regulation.
Original languageEnglish
Pages (from-to)729-732
JournalJournal of Medical Ethics
Issue number11
Publication statusPublished - Nov 2016

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