It is being reported that one person has been left in a coma and five others are in a critical condition in hospital after taking part in a phase 1 drug trial in France.
Phase 1 clinical trials test new drugs in healthy volunteers to evaluate their safety. In 2006 in the UK six people were left critically ill after taking part in a phase 1 trial of a compound called TGN1412. Following this incident the UK Government’s report said the problem of withholding phase 1 trial data needs to be addressed, as better sharing of such information could help to avert such disasters.
Dr Ben Goldacre, co-founder of the AllTrials campaign for clinical trial transparency, said:
“We have a responsibility to do all we can to make phase 1 trials as safe as possible for those who are brave and altruistic enough to volunteer for them. That means learning from past mistakes wherever we can. The medical, academic and regulatory community have still not fixed the known problems around phase 1 trial transparency that were identified during the UK government’s own inquiry into the TGN1412 trial. We do not yet know what went wrong in this phase 1 trial in France. But for as long as we continue to allow dangerous secrecy to persist around such trials, we make these disasters more likely.
“The UK medical, academic and regulatory community must do all we can to ensure phase 1 trials are run as safely as possible. That means addressing all known, identified risks, including failure to share results.”
Read what Ben Goldacre wrote about phase 1 clinical trial transparency following the TGN1412 incident in his book Bad Pharma here:
Read what Sir Iain Chalmers, co-founder of the AllTrials campaign wrote about phase 1 clinical trial transparency following the TGN1412 incident in his 2006 letter to The Lancet.