A volunteer, rendered brain-dead when a clinical trial went disastrously wrong in France, has died in a Rennes hospital.
The trials of a new drug developed by Portuguese company Bial also triggered the hospitalisation of a further five patients who now have undergone tests and are said to be stable.
The patient died at Centre Hospitalier Universitaire de Rennes and of the other five patients admitted, four have neurological complications, but the severity their condition has not been specified. The fifth had no complications.
The hospital in Rennes have recalled a further 84 people who had volunteered to participate in the trials of the Portuguese drug. Ten were tested in Rennes on Saturday and have no "clinical or radiological abnormalities," according to doctors.
The new painkiller was being tested on paid volunteers by the private laboratory Biotrial for the Portuguese company Bial. The accident occurred on Thursday as part of a Phase 1 clinical trial, according to the French Ministry of Health.
A statement from Bial, led by António Portela, today lamented the death of the volunteer and assured that it is monitoring the remaining hospitalised patients.
"The University Hospital of Rennes has just declared the death of the volunteer who was in a state of brain death, after participating in a Phase 1 clinical trial with an experimental molecule of BIAL, that was being held in a clinical trial unit in France.
"Our thoughts and solidarity go out to the family of this volunteer.
"BIAL will keep following the hospitalised volunteers and working closely with the Health Authorities to understand the causes of this tragic and unfortunate situation."
Biotrial conducts clinical trials for various pharmaceutical companies and employs 300 people, 200 of them in Rennes. The company stated that it operates in accordance with international guidelines for clinical trials of drugs on people; "108 healthy volunteers participated in the trial of this new drug without moderate or severe adverse reactions."
The test was approved by the French Regulatory Authorities, the French Ethics Committee and was in accordance to clinical trial laws.
Infarmed, which regulates the drug industry in Portugal, commented that the experimental drug "is not being used in any clinical trial in Portugal."
See also:
