Still a lot of gray areas. The Minister of Health Marisol Touraine took stock Thursday, February 4 on the consequences of the accident that occurred on January 10 in the context of thephase 1 clinical trial in Rennesand produced by the company Biotrial.
First lesson: it is too early to identify the causes of the accident which led to the death of one of the six hospitalized volunteers. The other five were able to return home. “They will benefit from a complete reassessment of their state of health at the end of February, by the neurology department of the Rennes University Hospital. At this stage, the doctors consider it premature to pronounce on their definitive cure”, a asserted Marisol Touraine.
As for the other 75 people who took part in the study, they saw a doctor and underwent an MRI. The minister wanted to be reassuring during the press point, resumed in a press release: “the clinical and radiological abnormalities present in hospitalized patients were not found in any other volunteer”.
A lack of information and reporting
What about the responsibility of the Biotrial laboratory? The progress note from the General Inspectorate of Social Affairs (IGAS), handed over to the minister, notes “three major shortcomings” on the part of the laboratory concerning the conduct of the study and the management of the crisis.
First failure: “the laboratory did not keep sufficiently informed of the state of health of the first hospitalized volunteer”. On January 11, the day after the accident, the laboratory carried out a new administration of the molecule among other volunteers. IGAS considers that the laboratory has not given itself the means which would have enabled it to decide whether or not to continue the clinical trial.
Second problem, the laboratory did not formally inform the other volunteers of the accident which occurred on January 10, which did not make it possible to obtain “informed” consent on the continuation of the clinical trial.
Finally, the IGAS inspectors believe that this accident should have been declared without delay to the National Medicines Safety Agency (ANSM). However, the laboratory did not make a formal declaration until four days after the hospitalization of the first volunteer, “and three days after the decision to discontinue the trial”.
Investigations continue
Despite these shortcomings, IGAS does not consider that the authorization granted to the Biotrial laboratory to conduct tests should be suspended.
The mission of the IGAS inspectors continues to try to understand the exact causes of the accident.
The final report should be delivered before the end of March. Case to follow.
Read also: Rennes clinical trial: what we know about the accident
Rennes clinical trial: the ANSM publishes the chronology
