EFPIA statement on the tragic clinical trial events in France
15.01.16
While we are unable to comment on the trial itself, we would like to underscore that severe adverse reactions among healthy volunteers are extremely rare. There are currently 8,000 trials ongoing around Europe, at different stages of the research process, and each is subject to rigorous, independent ethical and scientific approval.
Rather than speculate as to why this tragic incident has happened, it is vital that we now seek to identify precisely the reasons behind its occurrence. It is furthermore essential that we learn from this experience and apply any knowledge accrued to any future clinical trials.