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.
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 Paris prosecutor's office said an investigation had been opened.
Touraine said that she was determined to shed light on what happened.