Clinical trials at the IHU of Marseille: restrictions on clinical trials eased by the medicines agency
The Marseille IHU seems to be moving in the right direction. The drug agency will ease the restrictions imposed on this institute formerly led by Didier Raoult in terms of clinical trials without lifting them entirely given its still “unsatisfactory” attitude. “Research involving humans (RIPH) will be able to resume but under certain conditions,” declared the National Medicines Safety Agency (ANSM) in a press release, judging that the IHU was still not applying it in a “completely satisfactory manner.” ” regulations.
Under the direction of Professor Didier Raoult, who was dismissed last year, the IHU of Marseille was the framework multiple clinical trials which did not respect the ethical rules in force, for example on patient consent. If Didier Raoult, now widely discredited by his peers, acquired great notoriety during the Covid crisis, in particular by defending without any real basis the therapeutic interest of hydroxychloroquine, these failings date back well before the pandemic.
An ANSM investigation
But it is in the wake of this health crisis that the ANSM has carried out in recent years an investigation into IHU practices. These investigations notably led it to restrict the conditions of clinical trials at the institute at the end of 2022, leading it to suspend all trials in force. The ANSM had notably requested a full review of current research, and that which had given rise to publications over the past five years. It also required the implementation of internal training in the regulation of clinical trials.
Now headed by Professor Pierre-Édouard Fournier, long close to Didier Raoult, the IHU – in concert with its supervisory authority, the Marseille hospitals (AP-HM) – has implemented the requested actions, according to the ANSM , which therefore lifts its “injunctions” in force. But the Agency is not entirely satisfied: it judges, in a report sent alongside its press release, that the IHU does not seem “to have fully taken stock of the existing regulatory frameworks in terms of patient care”.
In particular, the publication online in the spring of a new study on the effects of hydroxychloroquine, co-signed by Didier Raoult. The professor insisted that it was only “observational” and therefore did not constitute a clinical trial, but this interpretation is open to question. The ANSM, which previously took legal action regarding this studytherefore maintains restrictions: it now requires the IHU and the AP-HM to transmit a quarterly report of clinical trial projects, as well as prescriptions for treatments outside of marketing authorization (AMM).
