Biotrial criticised over fatal Phase I study by France's social affairs inspectorate

France's social affairs inspectorate (IGAS) published its report (here​ – in French) today, explaining that the protocol approved by ANSM – the national drug safety agency – was not at fault.

Instead the inspectorate said the way it was implemented by Rennes-based Biotrial was flawed, accusing the contract research organisation (CRO) of major shortcomings in its management of the study.

These failings included that Biotrial continued to administer the drug to volunteers in the cohort after the first member of the group was sent to hospital and that it failed to confirm patient consent before beginning the study.

Communication breakdown​

The IGAS reviewers also said Biotrial and Bial – the Portugal-based drug company that developed BIA 10-2474 – did not inform French health authorities of the adverse events in a timely manner.

The first volunteer was admitted to hospital on January 10 suffering neurological symptoms. However, according to the report, Biotrial and Bial did not inform authorities until January 14.

They also said the companies failed to implement enhanced monitoring of participants after the study was halted on January 11.

Biotrial has previously denied any wrong doing. The firm did not respond to a request for comment.

French Health Minister Marisol Touraine will present IGAS' findings today.

UPDATE:​

In an official statement released this afternoon Biotrial said it was shocked by the conclusions detailed in the report.

“Biotrial deplores this situation, especially since it has always strictly respected the test protocol validated by the ANSM, and that it has been shown that it is the Portuguese Laboratory Bial’s compound, by it unexpected and unpredictable toxicity, which is at fault for the accident.​"