Clinical trials – NHS Confederation

The new EU Clinical Trials Regulation

A new EU Clinical Trials Regulation entered into force on 16 June 2014, introducing a raft of changes to the existing, controversial, EU Directive. The Directive (Directive 2001/20/EC), aimed to harmonise the requirements for clinical trials across the EU, whilst ensuring the safety of clinical trial participants, the ethical soundness of trials and the reliability and robustness of data generated. While achieving some of its aims, the Directive has also increased the administrative burden and costs of conducting clinical trials in the EU significantly, and caused considerable delays in launching new trials. The NHS European Office has published a briefing explaining some of the important changes the new EU Regulation will bring and how NHS research and patients will benefit. Download our briefing and our Infographic, and read our blog on the new EU Regulation.

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