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The new EU Clinical Trials Regulation

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The new EU Clinical Trials Regulation: how NHS research and patients will benefit” outlines the key issues for NHS organisations arising from the new EU Regulation on clinical trials, which will replace the existing Directive from July 2016. The Regulation is directly applicable and the UK Clinical Trials Regulation 2004 will therefore be repealed. The European Commission's own figures show that from 2007 to 2011 the number of applications to carry out clinical trials in the EU fell by 25 per cent, while costs increased significantly and the delays for launching a clinical trial rose by around 90 per cent. Given the increasing importance of clinical research to the NHS, the NHS Confed worked closely with a range of stakeholders to bring about the changes, and believes these new rules are an important step in enabling the NHS to increase the delivery of high-quality research and bring clear benefits for patients.

The publication will be highlighted on the NHS European Office’s Clinical Trials webpage.

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