Phase I Death in France: An Update on ANSM’s Investigations

Regulatory NewsRegulatory News | 05 February 2016 |  By 

New information from France’s National Agency for Medicines and Health Products Agency (ANSM) was released this week on the Phase I clinical trial halted last month after the death of one healthy volunteer and the hospitalizations of five others.

ANSM said Thursday that it “is pursuing its investigations in an aim to identify the factors which led to the dramatic accident which occurred 3 weeks ago.” The agency said this work is meant to supplement other investigations from the judiciary authorities, the French General Inspectorate of Social Affairs (Inspection Générale des Affaires Sociales) and the Ministry of Health.

The trial was a first-in-human trial of Bial’s fatty acid amide hydrolase inhibitor and involved 128 healthy volunteers, 90 of whom received different doses of the drug. 

Nineteen days after contract research organization (CRO) Biotrial dosed volunteers with 20 mg of the experimental drug, the CRO began treatment with a 50 mg dose on eight volunteers. On the fifth day of dosing, 10 January, one volunteer was hospitalized, though it wasn’t until 14 January that Biotrial informed ANSM of the serious adverse events.

On 11 January, a day after the hospitalization, seven other volunteers received another 50 mg dose. The hospitalized volunteer went into a coma later on the 11th and Biotrial and the sponsor Bial agreed to discontinue the trial. Five others were hospitalized between 13 and 15 January.

"All five volunteers hospitalized following the Bial study have returned home and two are being treated at centers close to their homes," Biotrial said on Twitter on Friday. The company also said "no critical observations were reported by the ANSM and we have responded to all comments."

The ongoing ANSM investigations include:

  • Continuation of the inspection work ANSM has performed on the site of the research center in Rennes, France;
  • Search for the medical causes which led to the death of one volunteer and serious consequences for four others. For this, ANSM said it has appointed clinical experts in charge of analyzing the available medical data gathered to date;
  • The creation of a temporary specialist scientific committee (known as Comité Scientifique Spécialisé Temporaire), which gathers French and European toxicology, pharmacology and neurology experts and clinicians.

ANSM said the special committee, created 21 January, will explore all the pharmacological and toxicological hypotheses which could have led to the accident, including all of the pre-clinical and clinical data. On 15 February, the committee will meet and ANSM said the list of experts and the agenda will be published at least two days before the meeting. This committee's report will also be made public.

The UK’s Royal Statistical Society said in a statement that “there are clear statistical reservations about the study-design,” and it urged the French investigators to include independent statistician-members.




© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy