France orders Biotrial to submit action plan or face licence suspension
An inquiry has found fault with both companies involved in a clinical trial in France that left one patient dead and five others hospitalised.
|M.Touraine& Prof. G.Edan|
Touraine also unveiled a plan to tighten up regulations governing the conduct of clinical trials, while Biotrial has been ordered to come up with an action plan to make sure the tragedy can never happen again. Failure to do so will result in Biotrial having its licence to operate suspended, said the Minister.
The IGAS launched the probe in January in the wake of the death of Guillaume Molinet, which occurred in a first-in-man trial at Biotrial’s phase I trial facility in Rennes.
The trial involved 90 healthy volunteers who were given Bial’s BIA 10-2474 - a candidate drug for mood and motor disorders associated with neurodegenerative disorders and anxiety.
The agency had no issues with France orders Biotrial to submit action plan or face licence suspension the protocol used in the trial as approved by France’s medicines regulator the ANSM, but said the implementation of the trial had a number of shortcomings.
In particular, the IGAS found that Biotrial continued to administer the drug to patients even after the first patient was taken to hospital, while the CRO – and Bial - also delayed reporting the adverse reactions to the ANSM.
The first hospitalisation took place on 10 January but dosing was not halted until the following day and the adverse events were not reported until 14 January.
Touraine said the government plans to tighten up the conditions for securing approval for first-inman studies, as well as reporting requirements, and will ask the ANSM to inspect all clinical trial facilities in France and remind them of their compliance obligations.
Meanwhile, the matter has been elevated to the EU level, with two working groups set up at the Commission to see how guidelines on the protection of healthy volunteers in clinical trials can be strengthened.(Ver)
La molécula que se estaba probando es un cannabinoide (de origen biológico; no derivado del cannabis) para fabricar un nuevo producto del grupo farmacéutico portugués Bial, de larga experiencia en este sector. Es una nueva molécula que no se está ensayando en España y que en Francia estaba en la fase 1, es decir, la primera etapa clínica, con personas sanas, después de haber pasado con éxito la etapa preclínica (con animales). Biotrial, por su parte, es un centro especializado con más de veinte años de experiencia. Touraine ha asegurado que, a pesar de la buena reputación de ambas firmas, se hará una profunda investigación para comprobar que se han respetado todos los protocolos. (Más)