鈥楽erious accident鈥 shuts down French drug trial
Print Edition
ONE person has been left brain-dead and five others hospitalized after a “serious accident” during a drugs trial in France, Health Minister Marisol Touraine said yesterday.
She said the six volunteers had been taking part in a “trial of an oral medication being developed by a European laboratory” in the northwestern city of Rennes on Thursday.
Portugal-based Bial lab is the manufacturer of the experimental medicine.
Touraine said the drug, which was being tested in a Phase I trial in France by Biotrial for Bial, contained neither cannabis nor any substance derived from cannabis. A person familiar with the situation had said it was a cannabis-based painkiller.
“A serious accident took place,” the minister said, adding that the study had been halted and all volunteers taking part recalled.
The study was a phase one clinical trial, in which healthy volunteers take a prototype medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule,”, the minister said in a statement. Ninety people were taking part in the study.
Clinical trials typically have three phases to assess a new drug or medical innovation for safety and effectiveness. Human participation in such trials and scrutiny by outside watchdogs are essential for obtaining market authorisation.
Phase one entails a small group of volunteers, and focuses only on safety.
Phase two and phase three are progressively larger trials, typically involving hundreds or thousands of volunteers, to assess the drug’s effectiveness, although safety remains paramount.
The company conducts its phase one trials at a 150-bed facility in Rennes and also in Newark, New Jersey, from where it carries out “a large variety of early clinical studies,” according to its website. Biotrial says it is able to fast-track early patient studies by “combining the favorable regulatory environment in Western Europe with fast and efficient patient recruitment in Eastern Europe.”
The Paris prosecutor’s office said an investigation had been opened.
Touraine vowed to “shed light on” what happened and has called for an inspection of the research site.
Every year thousands of volunteers take part in such clinical trials. Mishaps are relatively rare, but in 2006 six men were hospitalized in London while taking part in a similar trial.
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