Improving safety of first-in-human clinical trials

The European Medicines Agency started a review of the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation. This is being done in cooperation with the European Commission and the Member States of the European Union.

The review will identify which areas may need to be revised in the light of the tragic incident which took place during a Phase I first-in-human clinical trial in Rennes, France, in January 2016. The trial with  BIA 10-2474 for Portuguese pharmaceutical company Bial, led to the death of one participant and hospitalization of five others.

The EMA’s review will take into account the findings from two in-depth investigations into what went wrong during this trial, one carried out by the Temporary Specialist Scientific Committee (TSSC) set up by the French medicines agency ANSM and the other by the Inspection générale des affaires sociales (IGAS), the inspectorate for social affairs in France.