EMA revising the guideline on first-in-human clinical trials

In light of some tragic and fatal outcomes that have occured in early clinical trials, the European Medicines Agency, in cooperation with the European Commission and the Member States of the European Union, is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants.

The revised guideline is open for public consultation until February 28, 2017. Comments should be sent to FIH-rev@ema.europa.eu  using the template provided.

EU and international guidelines are in place to ensure that first-in-human clinical trials are conducted as safely as possible. The EMA’s existing guideline, released in 2007, 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.