EMA Begins Review of First-in-Human Trial Safety Following Patient Death

Regulatory NewsRegulatory News | 27 May 2016 |  By 

The European Medicines Agency (EMA) on Friday said it's reviewing its standards for first-in-human clinical trials after an incident during a trial in France last January left one patient dead and five others hospitalized.

The trial was conducted in Rennes, France by contract research organization Biotrial, on behalf of Portuguese pharmaceutical company Bial.

During the trial, a patient was hospitalized five days after receiving an increased dose of Bial's investigational compound BIA 10-2474. Despite the hospitalization, seven other participants were dosed with the drug the following day, though the companies agreed to halt the trial after the first patient went into a coma. Over the next three to five days, five other participants were hospitalized for neurological injuries.

Despite launching the review, EMA says that Phase I trials are extremely safe.

"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," the agency said.


EMA says its goal is to develop a concept paper elaborating on any proposed changes to its clinical trials guidance resulting from the review. After releasing the concept paper, the agency says it will open a public consultation into its proposal in late 2016.

EMA says its review, which will be done in collaboration with the European Commission (EC) and EU member states, will be based on the findings of two "in-depth" investigations into the fatal trial.

The investigations were carried out by two French bodies, ANSM's Temporary Specialist Scientific Committee (TSSC) and France's Inspectorate for Social Affairs (IGAS), to determine "what went wrong" during the trial.

According to EMA, "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."

Initially, EMA says the review will be carried out by two small expert groups before moving to an "EU-wide" discussion. EMA says the two groups will be looking into the preclinical data requirements needed to justify first-in-human trials, as well as design improvements to make such trials safer for human participants.

On Monday, French Minster of Health Marisol Touraine said that France will also be reviewing the recommendations made in the reports to enhance clinical trial safety nationally, and will be sending trial records for the 90 participants involved in the Bial/Biotrial study to the EC to aid in the EU-wide review.


TSSC Report (French)

IGAS Report (French)


© 2023 Regulatory Affairs Professionals Society.

Tags: Bial, Biotrial

Discover more of what matters to you

No taxonomy