French investigators to Biotrial: You should have stopped fatal study earlier

By Ben Adams

French Health Minister Marisol Touraine has criticized the CRO behind a botched drug trial that has seen one die and 5 others seriously ill for failing to stop the study.

Presenting the main findings in the investigators' initial report Thursday, Touraine, as quoted by Reuters, said CRO Biotrial "should have halted the tests" after the first person was hospitalized. This didn't happen, however, and 5 more people were given the medicine the next day.

Biotrial was running a Phase I trial in its home base of Rennes, France, on behalf of Portuguese drugmaker Bial, administering a medicine that blocks the enzyme FAAH to treat anxiety. The drug's mechanism is well-known to the industry but had not shown safety concerns in previous testing.

In all 90 patients had taken the drug, but in January, 6 trial participants took a higher dose form of the treatment, with one becoming brain dead and later dying. Five others were seriously ill but are now slowly improving.

The initial report found that the first accident with the drug was on a Sunday evening--yet authorities were not alerted until the following Thursday.

Touraine said the lab also should have been quicker about warning the authorities about the accident. She added that the firm should also have "explicitly asked other participants whether they wanted to stay in the test trial."

But she was unwilling to place full blame on the two firms and said that no regulations were breached and it was impossible at this stage to establish exactly what went wrong. She added: "The tests were carried out in compliance with current regulations."

Biotrial has yet to comment on these latest developments and did not return a call to FierceBiotech.

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