Six people have been hospitalized and one person is brain-dead in a trial of a new drug in France, the country’s health minister said in a statement.
No details have been released yet about the drug or its manufacturer, but Marisol Touraine, France’s minister for social affairs, health and women’s rights, reported that a “serious accident” during a Phase 1 clinical trial of an oral drug made by a European lab.
Clinical trials are typically conducted in three phases. Phase 1 trials focus primarily on the drug’s safety and side effects, while Phases 2 and 3 focus on its efficacy.
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. Those sickened by the drug are being treated in the University Hospital of Rennes.
The drug’s maker is reportedly stopping the trial and recalling all volunteers.
Such adverse events during a Phase I clinical trial are rare.
The European Union has very strict standards for performing clinical trials, Jayne Lawrence, chief scientist at the Royal Pharmaceutical Society, said in a statement. “Those in charge of the trial would have had to have shown they had done everything they could to protect patient safety before the trial was allowed to go ahead,” she added.
Because Phase I trials are used to determine a drug’s toxic effects, they “are inherently risky, as unexpected events can — and do — occur,” Carl Heneghan, a professor of evidence-based medicine at the University of Oxford, said in a statement. “Phase 1 trials, therefore, pose significant practical and ethical issues.”
The New York Times reported a similar event in March 2006, when six previously healthy young men in England were seriously sickened after being injected with an immune-system stimulant known as TGN1412 in a Phase 1 trial.
We will update this story as more details become available.
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