Revision European guideline first-in-human studies
The European Medicines Agency (EMA) has published a proposal to review the European guideline for first-in-human studies. The reviewed guideline is open for public consultation until the 28th of February 2017.
The current EMA guideline for first-in-human studies dates from 2007. The aim of the reviewed guideline is to further protect the safety of human subjects. The reviewed guideline contains new insights which have been gathered in the last ten years, including the lessons learned from a serious incident during a first-in-human study in January 2016 in Rennes, France.
The EMA aims to publish the final reviewed guideline in the first half of 2017.
> Revising the guideline on first-in-human clinical trials (EMA)
> First-in-Human Clinical Trials — What We Can Learn from Tragic Failures (NEJM)