Medical trials typically have three phases to assess a new drug or device for safety and effectiveness. Phase I entails a small group of volunteers, and focuses only on safety. Phase II and Phase III are progressively larger trials to assess the drug's effectiveness, although safety remains paramount.
A 'serious accident' during a drugs trial in France has left one person brain-dead and five hospitalized, reported Health Minister Marisol Touraine. Media reports said the drug was a cannabis-based painkiller, but this was denied by the health ministry.
‘A 'serious accident' during a drugs trial of an oral medication being developed by a European laboratory in France has left one person brain-dead and five hospitalized, reported Health Minister Marisol Touraine.’
She said, "The six had been taking part in a trial of an oral medication being developed by a European laboratory in Rennes, northwest France."
The minister said, "A serious accident took place. The study has been halted and all volunteers taking part recalled. The study was a phase one clinical trial, in which healthy volunteers take the medication to evaluate the safety of its use, tolerance and pharmacological profile of the molecule."
The Paris prosecutor's office said an investigation had been opened.
Touraine said that she was determined to shed light on what happened.