EU regulator's proposals to revise guidance on first-in-human clinical trials

The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union, is proposing changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants.

These changes are outlined in a new concept paper which has been released for public consultation. Comments on the proposals should be sent to FIH-rev@ema.europa.eu until September 30, 2016 using the form provided.

The EMA’s action was largely prompted by a Phase I clinical study, conducted by French clinical research organization Biotrial, recently resulted in the death of one enrolled subject and neurological injury to four others. The study had focused on BIA 10-2474, an Investigational New Drug (IND) manufactured by Portugal’s largest drugmaker Bial.