Accident in clinical trials and compensation for victims
On January 15th 2016, we learned through the press that a dramatic event had just occurred during the phase 1 clinical trial performed in France. This is the first accident of this severity since the trial of a German biotechnology company in March 2006 during also a phase 1 trial in England. At the time of writing the responsibilities of different participants (promoter, CRO, CMO…) are not known and investigations are ongoing; but, regardless of the responsible, the victims and their dependents will ask to be compensated and insurance mechanisms come into play. After reviewing the facts we will discuss about the insurance arrangements required by French regulations in terms of clinical trials victims compensation.