EMA Highlights: EMA wants to improve safety of first-in-human trials

by Gary Finnegan: The EU drug watchdog is reviewing the guidelines on first-in-human clinical trials in response to the tragic death of a participant in a trial in Rennes, France, early this year.

The phase I trial also saw five other participants hospitalised, reigniting concerns about the design of early stage clinical studies. Phase I trials, which are essential to drug development, are typically conducted in healthy volunteers or paid participants.

The European Medicines Agency’s (EMA) review will take into account the findings from two in-depth investigations into what went wrong during this Rennes 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.

Both reports include a series of recommendations regarding the requirements for authorisation and conduct of first-in-human clinical trials for further examination by the international regulatory and public health community.

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 minimise 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.

EU guidelines are in place to ensure that these clinical trials are conducted as safely as possible. These guidelines include the requirement for extensive studies, including in animals, to gather information about a medicine before it is given to humans.

Severe adverse reactions in healthy volunteers such as those observed in the trial in Rennes are extremely rare during clinical trials. Since 2005, approximately 14,700 phase I clinical trials (with participation of 305,000 subjects) have been conducted in the EU, including 3,100 first-in-human studies. Only one other severe incident has been previously reported in that time in the EU.