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Jun 6, 2016

EMA initiated major review after fatal French Phase I trial....

EMA Launches Major Review After Fatal French Drug Trial

Megan BrooksMay 27, 2016

The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union, has launched a major review of guidelines for the conduct of phase 1 clinical trials, with an eye toward making them safer.

"The review will identify which areas may need to be revised in the light of the tragic incident which took place during a phase 1 first-in-human clinical trial in Rennes, France, in January 2016," the EMA said in a statement.

As reported previously by Medscape Medical News, one previously healthy participant in the phase 1 trial of an investigational analgesic medication (Bia 10-2474) died and five others were hospitalized after developing serious neurologic problems. The trial was carried out by Biotrial, a clinical trials company, for the Portuguese pharmaceutical laboratory Bial.

Bia 10-2474 is a molecule that acts on the endocannabinoid system and was in development for treatment of motor disorders, neurodegenerative disorders, and anxiety disorders. All trials of the drug have been suspended.

In their review, the EMA will consider the findings from two in-depth investigations into what went wrong in the trial. One was carried out by the Temporary Specialist Scientific Committee set up by the French medicines agency Agence nationale de sécurité du Médicament et des produits de santé (ANSM) and the other by the Inspection générale des affaires sociales (IGAS), the inspectorate for social affairs in France.

The IGAS report concludes that Biotrial and Bial are partly responsible regarding the choice of the dose administered and the delay in alerting authorities and other trial participants.

In a news release, Biotrial said it "strongly contests" the conclusions of the IGAS report.

Both reports provide recommendations on requirements for authorization and conduct of phase 1 clinical trials. The IGAS report calls for strengthening of conditions for authorization of clinical trials, including first-in-human, and stricter rules applying to the assessment by the ANSM early-phase trials.

The EMA says it will focus on "best practices and guidance," with the aim of having a concept paper by July that identifies "areas for change and proposals to further minimize the risk of similar accidents." This paper will form the basis for a European Union (EU)-wide review of the guidelines. The process will include targeted discussions with stakeholders and a public consultation on proposed changes later in 2016, they said.

The EMA review is already underway, with two groups of experts doing "preparatory work," the agency said. One group is looking at preclinical aspects and the data needed from laboratory tests or animal studies to safely initiate initial tests in humans. The other group is looking at clinical aspects of the design of phase 1 trials and how these could be improved to better ensure the safety of study volunteers. "This will lead into one EU-wide expert group discussion on revision of guidelines."

What happened in the Rennes trial is "unprecedented in our country," French Health Minister Marisol Touraine said during a press conference earlier this week.

According to the EMA, severe adverse reactions in healthy volunteers are "extremely rare" during clinical trials. Since 2005, roughly 14,700 phase 1 clinical trials involving some 305,000 participants have been conducted in the EU, including 3100 first-in-human studies. Only one other severe incident has been previously reported in that time in the EU, the agency says.

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