PRESS RELEASE - May 12th, 2016
ANSM Final Report: Biotrial not found responsible for the clinical trial accident in Rennes
Rennes, May 12th, 2016
Biotrial, Medical Research Center in Rennes, has received the final report from the French National Agency for the Safety of Medicines and Health Products (ANSM) regarding the Phase I Clinical Trial that was performed for the Portuguese Pharmaceutical company, Bial.
This report confirms that Biotrial is not being held responsible in the cause of death of the volunteer and that no element existed that could have foreseen the serious adverse events that occurred. The trial was performed in accordance with the conditions outlined in the protocol and with the expertise required for this type of study.
During its inspection, the ANSM made a number of observations that could require the management system and the monitoring of certain activities performed by Biotrial to be reinforced. However, these items are neither linked with the accident, nor with the health status of the volunteers having participated in January’s clinical study. No fault was identified in the report in regards to the monitoring and surveillance of the volunteers having participated in the study for the Bial compound.
During the two unannounced inspections, following the accident in January, 2016, the ANSM made observations that were not considered to be critical and which related to:
- forms completed retroactively for the process of task delegation and the delayed signature of one of the dose escalation decisions
It was noted, however, that the escalation steps were properly performed based on the expected practices and based on the protocol that was validated by the ANSM – and for which the provisions asked that the decision be made by both the sponsor (the Laboratory Bial) and the investigator (Biotrial research center).
- the delay in notifying the ANSM of urgent safety measures.
This alleged delay is contested by Biotrial.
- transcription errors from the source data to the case report form
The data was included on other documents and was taken into consideration for dose escalation decisions.
The observations made by the ANSM were in no way a factor in the cause or the worsening of the volunteers’ conditions during this clinical trial, which the ANSM noted in its conclusions:
“The inspectors’ findings […] do not allow the formulation of a hypothesis as to the origin of the serious adverse events that occurred […] and “no concrete item was identified which would point to the fact that Biotrial was aware of the existence of any specific risk for the volunteers […].
As soon as the preliminary reports and inspections following the accident were received, Biotrial immediately took appropriate corrective actions in light of these observations in order to reinforce its quality assurance system. Certain corrective actions suggested by Biotrial have already been considered as satisfactory to the ANSM and others will be verified onsite during subsequent inspections.
Guillaume Didier +33 6 74 08 27 17
BIOTRIAL is a private center for medical research licensed by the Ministry of Health (based in Rennes, with an International presence). It conducts Phase I clinical trials, i.e. for a first administration to humans, on behalf of laboratories and biotechnology companies.