On 23 May 2016, the General Social Affairs Inspectorate (IGAS) published its final report on the Phase I FAAH (fatty acid amide hydrolase) inhibitor trial in which one volunteer died and several others were hospitalised with neurological damage. On the same day, Marisol Touraine, France’s Minister of Health, issued an action plan aimed at strengthening safety for clinical trial volunteers.
The IGAS concluded that the trial was authorised by the French National Agency for Medicines and Health Products Safety (ANSM) and the ethics committee in compliance with the applicable regulations and guidelines, but questioned their risk assessment of the product (BIA 10-2474). However, it found BIAL, the Portuguese sponsor of the trial, and BIOTRIAL, the French CRO conducting the trial, liable for the accident, for the following key reasons:
- Dosage administered.
- Non-suspension of the trial following the hospitalisation of the first trial subject.
- Failure to inform other trial participants.
- Delay in reporting the incidents to the health authorities.
Touraine’s four-point action plan demands that in relation to the FAAH trial:
- BIOTRIAL submits an action plan, including risk minimisation measures, within one month.
- The ANSM’s specialised scientific committee (CSST) examines the 90 clinical files of healthy volunteers.
In addition, more generally, the Minister has called for:
- Conditions for authorising clinical trials in France, in particular Phase I trials, to be strengthened (for example, through inspections of all authorised trial centres; a monthly report on unexpected serious adverse events; the creation of a special group within the ANSM to evaluate first-in-man trials; and the establishment of a national secretariat of ethics committees).
- A comparative analysis of current practices regarding Phase I studies at EU level
On the basis of the IGAS and the CSST reports, the EMA is currently reviewing its 2007 guideline on first-in-human clinical trials (see Blog post: ANSM issues measures regarding first-in-human trials in wake of French trial tragedy). Its concept paper is due in July.
In parallel, in France, criminal proceedings have been opened against ‘persons unknown’ for involuntary manslaughter and unintentional injury with respect to the trial.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, May 2016 Issue (Thomson Reuters).