Volunteer dies after Phase I clinical trial in France
Further five volunteers said to be critically ill in hospital in Rennes
A Phase I clinical trial at Biotrial in France has been halted and all volunteers recalled after a 'serious accident' that resulted in the hospitalisation of six people at the University Hospital of Rennes in France, one of whom was initially reported to be in intensive care and brain dead, but has now died, according to a local media report published yesterday (17 January).
Ten of the other 84 volunteers taking the experimental drug have been tested, but did not display any of the 'anomalies' of those admitted, the Rennes hospital said in its statement (in French).
The French health authority, the Agence Française de Sécurité Sanitaire des Produits de Santé (ANSM) was informed of the incident which happened during a Phase I clinical trial of an oral drug, being developed by Portuguese company Bial. The trial was performed in a licensed private institution specialising in carrying out clinical trials and was to evaluate the safety, tolerability, pharmacological profiles of this molecule in healthy volunteers.
The ANSM is to conduct a technical inspection of the clinical trial site. Marisol Touraine, Minister of Social Affairs, Health and Women's Rights, has ordered the General Inspectorate of Social Affairs (IGAS) to look into the organisation, methods and conduct of the laboratory involved in the trial.