French Health Minister Marisol Touraine said the “serious accident” occurred near Rennes, in the northwest of the country.
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The oral trial was initiated by Rennes-based Biotrial on January 7 and was in the first phase of testing, in which the drug is administered to healthy volunteers to evaluate its safety and patients’ tolerance.
Clinical trials are the key to getting that data – and without volunteers to take part in the trials, there would be no new treatments for serious diseases such as cancer, multiple sclerosis and arthritis.
It is rare for volunteers to fall seriously ill when testing new drugs.
The investigators and inspectors “are trying to understand… what could have happened and how it could have resulted in such an a tragic situation”, he said.
A total of 108 volunteers took part in the trial, 90 of whom received the drug at varying doses while the rest were given placebos. Bial added that initial testing for the drug started in June following toxicology tests.
According to the statement, the trial was being performed in a lincensed private institution that conducts trials of drug safety, tolerability, and pharmacology, in healthy volunteers.
France’s Health Minister Marisol Touraine and a neurologist said six men aged between 28 and 49 years were taken to hospital last week after taking part in a Phase1 trial of a new medication for the treatment of mood disorders including anxiety.
Three of those in hospital may have a “handicap that could be irreversible”, said doctors in Rennes, where the men are being treated.
“Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital”, the company said in a statement, according to Sky News. An inquiry after the incident called for more care to be taken in Phase 1 trials. The sixth volunteer shows no symptoms but is being monitored.
He said there was no known antidote to the drug because it had never been used on humans in that dosage.
Also, The Verge points out that Biotrial’s website contains a call for volunteers to participate in drug trials at Rennes and Newark, New Jersey.
The tragedy resembles a similar event in Britain in 2006 in which six men were almost killed by a drug aimed at modifying the immune system.
Ben Whalley, a neuropharmacology professor at the University of Reading, said standardised regulations for clinical trials are “largely the same” across Europe.
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“However, like any safeguard, these minimise risk rather than abolish it”, Dr Whalley added.
