Communication from Biotrial
February 5th, 2016 – Rennes, France
The management and the employees at Biotrial remain deeply affected by the death of one of our volunteers. We are fully committed to assisting his family, as well as the other five volunteers, for whom the latest news is reassuring.
All five volunteers originally hospitalized following the Bial Phase I study have returned home and two are being treated at centers close to their homes. Thorough examinations of the eighty-four other volunteers having participated in the study continue, to date seventy-five volunteers have been seen by Biotrial’s physicians and no anomalies have been found.
Throughout the Bial study and all studies performed at Biotrial, the safety and wellbeing of the volunteers is our utmost priority. The trial was conducted in full compliance with the international regulations and Biotrial’s procedures, in particular regarding the emergency procedures.
At this time we are able to communicate that we have received a preliminary draft of the National Agency for the Safety of Medicines and Health Products’ (ANSM, the French Competent Authority in charge of Clinical Trials) report. No critical observations related to Biotrial’s involvement were found during the investigation and we have responded to any comments. We are confident that our responses will shed light on any remaining questions from the ANSM, and that a final report will be available shortly.
Following the General Inspectorate for Social Affairs (IGAS) status report presented yesterday by Marisol Touraine, The French Minister for Social Affairs, Health and Women’s Rights, the certification to conduct clinical trials has been maintained, and our organization, working processes and professionalism have been noted. Regarding the alleged “major shortcomings” in the IGAS report, the items are not critical observations in relation to Good Clinical Practices and most of them have been underlined for the sole purpose of modifying legislation.