The British Journal of Clinical Pharmacology has published an editorial calling for improvements to the safety of clinical trials, following the tragic outcomes of the Bial clinical trial in January 2016, when five volunteers were hospitalised and one subsequently died.
The authors make several recommendations for learning from this tragedy, which include:
- Pre-clinical and clinical study data from this trial should be urgently released to allow lessons to be learnt for ongoing and future studies.
- Reviewers of clinical trials should ask for full pre-clinical study reports and full information on pharmacology, including drug and target interactions.
This is not the first time such calls have been made. 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:
Bad Pharma TGN1412 section
Bad Pharma TGN1412 section references
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.