- In the wake of a recent deadly clinical trial in France, the European Medicines Agency has initiated a comprehensive review of guidelines for first-in-human studies, Fierce Biotech reports.
- Back in January, six men were hospitalized, one of whom eventually died, after participating in a trial for an FAAH anxiety drug in early development by the Portuguese company Bial.
- While an investigation by France’s social affairs inspectorate (IGAS) found that both Bial and the French laboratory Biotrial did not break any existing laws, inspectors consider both companies responsible for several critical mistakes, including using an improper testing protocol and failing to halt the trial quickly.
The EMA will draw on both the IGAS report and an earlier investigation conducted by the French medical agency ANSM to determine how best to improve clinical guidelines, said Fierce.
IGAS’ investigation concluded Biotrial moved ahead with high-dose testing without checking in on a volunteer who had complained about blurry vision and headaches. Additionally, the companies allegedly failed to warn the other volunteers and took too long to report the incident to ANSM.
The tragic results – coupled with the fact that existing laws were followed, despite mistakes – appears to have spurred the EMA to initiate their review.
Both Biotrial and Bial have pushed back strongly against the conclusions of the IGAS report.
Biotrial said it had already put a plan of action in place after discussions with ANSM and that it is “astonished” by the IGAS report. “The center [Biotrial] deplores the methods, contrary to legal procedures, that were used to put together the report and that therefore remove all of its credibility,” the company wrote in a statement.
For its part, Bial argued that the decisions on escalating doses were properly taken.
The five other men who were hospitalized have since recovered.