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Private laboratory Biotrial was testing a pain and mood disorder medication for Portuguese pharma company Bial on humans for the first time, in a Phase I trial.
Details are starting to emerge in the European media about a clinical trial in Rennes, north-west France, that went seriously wrong and reportedly has killed one volunteer and led to five hospitalizations.
The incident is the worst of its kind to have taken place in France, which has launched three separate investigations to determine whether the tragedy was caused by an error in the trial’s procedures or in the substance tested, according to an article posted online on January 17 by the U.K. Guardian newspaper.
The private laboratory Biotrial was testing a pain and mood disorder medication for the Portuguese pharmaceutical company Bial on humans for the first time, in a Phase I trial to test the drug’s safety. 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. Six men in the group that received the highest dose suffered serious side effect and were hospitalized, the article noted.
Dr. Pierre-Gilles Edan, head of the neurology department at the Rennes hospital, said that three of the men were suffering a “handicap that could be irreversible” and another also had neurological problems. The sixth volunteer had no symptoms but was being monitored, according to the Guardian report.
The 84 other volunteers exposed to the drug have been contacted by hospital staff. Ten of them came in to be examined and did not have the anomalies seen in the hospitalized patients.
Bial is cooperating with the investigation and claims it followed international best practice in developing the drug. According to a company statement, “Our principal concern at the moment is taking care of participants in the trial.”
For more details, see the following article posted by Nature.com.