EMA to Review Safety in First-in-Human Clinical Trials

May 27, 2016

May 27, 2016.

The European Medicines Agency (EMA) has 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 (EU).

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 clincial trial in Rennes, France, in January 2016. The trial led to the death of one participant and hospitalization of five others.

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.

EMA’s work will focus on best practices and guidance. The aim is to agree a concept paper by July identifying areas for change and proposals to further minimize the risk of similar accidents.  The concept paper will form the basis for an EU-wide review of the guidelines. This process will include targeted discussions with stakeholders and a public consultation on proposed changes later in 2016.