New EU clinical trials regulation

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3710 (Published 05 June 2014) Cite this as: BMJ 2014;348:g3710
  1. Anna E Westra, postdoctoral researcher in medical ethics1,
  2. Wendy Bos, junior researcher1,
  3. Adam F Cohen, chief executive officer2
  1. 1Erasmus University Medical Centre, Department of Medical Ethics and Philosophy of Medicine, 3000 CA Rotterdam, Netherlands
  2. 2Centre for Human Drug Research, Zernikedreef 10, 2333 CL, Leiden, Netherlands
  1. a.e.westra{at}lumc.nl

Needs a few tweaks before implementation

On 2 April 2014, the European Parliament approved the new European Union Clinical Trials Regulation.1 This regulation will replace the Clinical Trials Directive, which has failed to achieve its goal of simplifying the scientific and ethical review of clinical trials in the EU.2 3 Unlike the directive, the regulation has binding legal force in all EU member states. Important innovations include a central database and a partly coordinated review system. Both of these steps could help simplify the review system and improve the quality of assessments.

However, when it drafted the regulation, quality improvement did not seem to be the European Commission’s main concern. Despite serious criticisms and several adjustments, the approved document may still impair, rather than improve, the quality of the ethical review of trial protocols.4 5 6 7 8 9 This puts the protection of European research subjects at risk.

Before discussing our two main concerns, we need to explain the new review system. Currently, all member states assess the request for authorisation of a multinational clinical trial independently of one another. To simplify and speed up authorisation, the European …

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