A Phase 1 drug in Frances left 1 man dead and others seriously injured.
Clinical trials lawyer Gene Matthews says that questions need to be asked about the design and conduct of the fatal Phase 1 clinical trial of painkiller BIA 10-2474 that was carried out by Biotrial (a Contract Research Organisation) on behalf of Bial (a Portuguese pharma company).
One man died following the clinical trial and several others were left seriously injured.
ANSM, the French national drug safety agency has released a timeline of events for the trial which confirms that the eight volunteers received the fifth of the highest dose escalation (50mg) of the drug that was being tested at the same time.
This is in contravention of European Medicines Agency (EMA) recommendations released in 2007 following the failure of a Phase 1 clinical trial in the UK at Northwick Park when a number of volunteers were left with long-term health problems after testing TGN1412.
The trial took place in Rennes. One man was hospitalised the same evening that the volunteers had received their fifth doses. The remaining seven volunteers received a sixth dose the next morning. The eighth man went into a coma the same day. Biotrial and Bial then discontinued the trial and notified ANSM three days later. Four of the volunteers are reported to have been left with brain injuries, and one man died.
The Royal Statistical Society (RSS) has issued a statement about the design of the French trial, asking for more information to be released. The RSS says there are “clear statistical reservations about the trial’s study-design” and asks French authorities to ensure that independent statistician experts are included in the investigation team.
The British Pharmaceutical Society has also called for early access to data following fatal drug trials.
While ANSM has published Bial’s laboratory’ clinical trial procedure the company has not released two other documents, the Investigational Product Dossier and the Investigator’s Brochure, citing commercial confidentiality as the reason.
Gene Matthews, a partner at Leigh Day who specialises in representing those injured in clinical trials, including four of the volunteers injured in the infamous Northwick Park clinical drug trial, said:
“The latest release of information about the Phase 1 trial in France raises serious questions about the design and conduct of the trial. It is difficult to understand why this trial was allowed to continue following the hospitalisation of one volunteer, seemingly having suffered a serious adverse reaction.
“It is shocking that the volunteers received the highest dose of the trial drug simultaneously, despite the clear guidance of the EMA. The medical and scientific communities, along with the general public, will want to understand how this could have happened some 10 years after the lessons of the Northwick Park TGN1412 clinical trial have supposedly been learnt.
“It is important that the Bial and Biotrial releases all the data it holds into the public domain as soon as possible so that the investigation team, and the wider community, can assess exactly went wrong with the trial.
“The future safety of clinical trials and the safety of patients depends on full transparency.”