On 31 March 2016, the French National Agency for Medicines and Health Products Safety (ANSM) adopted precautionary measures for first-in-human trials, following the suspension of Bial’s Phase I study of a fatty acid amide hydrolase (FAAH) inhibitor causing the death of one healthy volunteer and the hospitalisation of five others in early January. Clinical trial sponsors should now analyse pharmacokinetic data (in relation to clinical trial vigilance data) before moving from one dose level to another, or from a single administration dose to a multiple administration dose.
The ANSM simultaneously issued new guidance for sponsors on their clinical trial vigilance data reporting obligations, and implemented priority processing of suspected unexpected serious adverse reaction reports from Phase I first‐in‐human and subsequent trials on healthy volunteers. The guidance complements Circular 2016-61, adopted on 1 March 2016, which clarifies the existing obligation for sponsors to report “new facts” immediately to the competent authorities and ethics committee. After an interim report on the trial investigation established that the authorities were only informed four days after the first hospitalisation, the Circular now specifies that every serious adverse reaction causing the hospitalisation of a healthy volunteer is considered a “new fact” which must be reported on the day the sponsor learns about it, and must lead to the immediate suspension of the trial.
In addition, on 19 April 2016, the ANSM’s Temporary Specialist Scientific Committee on FAAH inhibitors, which was set up to investigate the trial, published its final recommendations, stating that:
- EU and international regulations and good practices in Phase I studies should be made stricter on a number of points.
- Broader access to clinical data of first-in-human studies should be discussed.
EU medicines regulators are awaiting the final outcome of the on-going investigations in order to assess whether any revisions to EU guidelines are required.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, April 2016 Issue (Thomson Reuters).