The Royal Statistical Society has called for more information to be disclosed regarding the tragic clinical trial in which a participant died with five others requiring hospitalisation.
The clinical trial BIA 10-2474, which took place in France earlier this month, saw six healthy volunteers receive daily dosing of the active drug in the trial’s multiple-administration dose phase. The trial was halted on 11 January after a participant became ill, and who later sadly died.
In a statement (PDF), the RSS welcomes the publication of the study-protocol for BIA-102474-101 which details, among other things, the chemical make-up of the drug. However, we also note that there are 'clear statistical reservations about the trial's study-design'.
It appears that the trial did not follow recommendations made in 2007 by the Royal Statistical Society’s Working Party on Statistical Issues in First-in-Man Studies in the aftermath of a different clinical trial (TGN1412) where six previously healthy men were treated at Northwick Park Hospital in London after suffering a serious reaction (cytokine release storm) from a monoclonal antibody drug.
The RSS calls for the investigator brochure (which usually describes pre-clinical studies in detail) to be disclosed, along with the escalated dose-levels and the regimen selected in the trial’s multiple-administration dose phase.
Professor Stephen Senn, who chaired the RSS working party mentioned above, said: 'Our thoughts are with the families of all the men in the affected cohort. Key recommendations in the RSS report cover proper risk assessment, sharing that assessment with all parties and the sharing of information across studies to improve the assessment of risk.
'We hope that, as the inquiry proceeds, these matters will be properly and expertly addressed not only by physicians but also by statisticians.'