EMA, in cooperation with the European Commission and the Member States of the EU, is proposing changes to current guidance on first-in-human clinical trials with the aim of improving strategies to identify and mitigate risks to trial participants. These changes are outlined in a new concept paper that has been released for public consultation. The release of the concept paper is part of a review of the EMA guideline published in 2007 that provides advice on first-in-human clinical trials, in particular on the data needed to enable their appropriate design and allow the initiation of treatment in trial participants. This review identified those parts of the current guideline that need to be amended to take into account the evolution of practices in the conduct of these studies since the guideline was first published. The review also takes into account the lessons learned from the fatal incident that took place during a Phase I first-in-human clinical trial in Rennes, France, in January 2016. Comments on the proposals should be sent to FIH-rev@ema.europa.eu until September 30, 2016.

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