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

By Gareth Macdonald

- Last updated on GMT


Related tags Clinical trial

French investigators reviewing the Phase I trial in which one volunteer died and five others were hospitalized in January have criticised CRO Biotrial over how it conducted the study.

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.


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.​"

Related news

Show more

Related products

show more

Automated metadata management in clinical trials

Automated metadata management in clinical trials

Content provided by Formedix | 01-Aug-2023 | White Paper

When it comes to efficient clinical study build, content is king. Most importantly: metadata content. In this blog, we explore the role of metadata in...

Small Molecule development – getting it right

Small Molecule development – getting it right

Content provided by Lonza Small Molecules | 20-Jun-2023 | Insight Guide

Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can...

Validate clinical study data with Formedix CORE

Validate clinical study data with Formedix CORE

Content provided by Formedix | 19-Jun-2023 | White Paper

In April 2023 at the CDISC Europe Interchange, we launched Formedix CORE, the first free-to-use, downloadable application encompassing the CDISC Open Rules...

The Right CDMO Can Unlock Faster Drug Development

The Right CDMO Can Unlock Faster Drug Development

Content provided by Lonza Small Molecules | 15-May-2023 | Interview

Drug development presents biotech companies with ever-changing challenges. Enabling a faster end-to-end process requires seamless flexibility and extensive...

Related suppliers

Follow us


View more