PRESS RELEASE - February 4th, 2016

IGAS* Status Report: Clarifications from Biotrial

PRESS RELEASE
Rennes, February 4th, 5.30 PM

The center for medical research, Biotrial, has learned through the press of the statement given by Marisol Touraine, Minister for Social Affairs, Health and Women’s Rights, about the IGAS status report.

The management and the employees at Biotrial remain deeply affected by the death of one of our volunteers. We are naturally fully committed to assisting his family, as well as the other five volunteers, for whom the latest news is reassuring.

Biotrial finds it unfortunate to learn of the findings of this status report, which was not established following the adversarial principle, through the press. Biotrial is fully cooperating with the current investigations in order to assess, in the fastest possible way, what caused this dramatic – and to this day unexplained – accident.

Biotrial is relieved that the IGAS status report confirms that the center is not accountable for the volunteer’s death, and that no fault has been identified in the accident that took place during the clinical trial of the molecule from the Portuguese pharmaceutical laboratory, Bial.

Biotrial reaffirms having strictly applied the precautionary principle and having rigorously complied with the protocols, in accordance with international standards that govern clinical trials – more specifically in regards to the timing of the pursuit of the trial, its suspension and its definitive termination after the volunteer (who has since died) was hospitalized.  

Regarding the three alleged “major shortcomings” found by the IGAS status report, Biotrial wishes to call attention to the fact that we are not a pharmaceutical laboratory but a private center for medical research, licensed by the Ministry of Health.

On the first two alleged shortcomings, i.e. the information about the medical condition of the first patient and the pursuit of the trial:
Biotrial had the volunteer hospitalized for further explorations at the first sign of light symptoms. During the night, news from the University Hospital was reassuring and his return was expected for the next day.

In this context, given the information on the medical condition of the hospitalized patient and in compliance with the rules governing clinical trials, suspension of the trial was not justified. An additional administration of the tested product was therefore administered at 8:00 AM to the other volunteers.

At 9:00 AM, Biotrial learned that the hospitalized volunteer was undergoing an MRI scan, and at 10:00 AM, was told that he had suffered a stroke (CVA). Though this diagnosis seemed disconnected from the clinical trial, Biotrial and the Portuguese pharmaceutical laboratory Bial decided, as a precaution, to suspend the administration of the product. There was therefore no further administration of the product after 8:00 AM on Monday.

On the third alleged shortcoming, i.e. not obtaining informed consent from the volunteers after the first incident:
Clinical trials are conducted according to extremely strict rules, standardized at the EU level, in regards to selecting volunteers and obtaining their informed consent. As the regulation currently stands, an additional collection of informed consent from the volunteers is not mandatory, unless the protocol approved by competent authorities is modified.

However, the precautionary principle led to Biotrial and Bial’s decision to suspend the administration of the test molecule as soon as the medical condition of the patient was known to have worsened.

The remaining volunteers were kept under strict medical supervision and were informed in real time by Biotrial of any developments.
 
We note that the main remarks of this status report relate to an evolution of the European legislation. The alleged shortcomings identified in the IGAS status report were in no way the cause the serious adverse effects which followed the administration of the pharmaceutical product BIAL BIA 10-2474.

*IGAS: Inspection Générale des Affaires Sociales, the French Government audit, evaluation and inspection office for health, social security, social cohesion, employment and labor policies and organizations.

Press contact:
Guillaume Didier +33 6 74 08 27 17
biotrial@vae-solis.com

About Biotrial:
BIOTRIAL is a private centre for medical research licensed by the Ministry of Health (based in Rennes and present internationally). It conducts Phase I clinical trials, i.e. for a first administration to humans, on behalf of laboratories and biotechnology companies.

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