Clinical trial accident leaves six critical, one ‘brain dead’
pharmafile | January 15, 2016 | News story | Medical Communications, Research and Development | France, clinical trial
Six patients have been left in a critical condition following a serious accident in a clinical trial at a French research facility, leaving one participant clinically ‘brain dead.’
The incident, which came to the French Health Ministry’s attention on Thursday night, is said to have happened at a private research laboratory in Renne. The participants in question are in care at the Centre Hospitalier Universitaire de Rennes.
Health Minister Marisol Touraine said in a statement that the trial – a Phase I study testing an as-yet unspecified compound in healthy volunteers – had been halted and all participants recalled. She added that the Social Affairs Inspectorate would conduct an inspection of the organisation’s practices and conduct during the clinical trial, and pledged to “get to the bottom… of this tragic accident”.
Media reports had initially suggested that the drug in question was a cannabis-based painkiller, but the Ministry later denied these suggestions.
Touraine is due to hold a press conference in Rennes to provide a further update at 14:30 today.
Update 15:34 GMT: The Portuguese pharma company Bial has been named as the drug company behind the clinical trial. Bial is Portugal’s largest pharma firm, and has as yet declined to comment on the matter, but planned to issue a statement.
Update 16:42 GMT: The clinical research organisation Biotrial has been named as the company conducting the clinical trial. A statement from the company says: “During a first in man study which was being conducted for a sponsor, serious adverse events related to the test drug have occurred in some subjects at our CPU.
“The trial has been conducted in full compliance with the international regulations and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital.
“We are in close and regular contact with the health authorities and Ministry in France.The priority at Biotrial remains the safety of our subjects…. We are working hand in hand with the Health Authorities to understand the cause of this accident.”
Joel Levy
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