Regulatory News

EMA Will Assess ANSM Review of Botched Clinical Trial in France

EU authorities could end up revising clinical trial guidelines depending on the outcome of French regulators’ investigation into Biotrial’s halted Phase I trial that has resulted in the death of one volunteer and the hospitalizations of five others.

“The French authorities have opened an investigation including verification that the clinical trial has been carried out according to standards,” European Medicines Agency (EMA) spokeswoman Rebecca Harding told Focus. “EU authorities will look carefully at the findings to determine if further measures are needed to protect health of clinical trial participants. Until EU authorities have the full picture, it is not possible to say whether any revisions to EU guidelines are required.”

The comments come as France’s National Agency for Medicines and Health Products Safety (ANSM) launched an investigation into the trial after it was halted. ANSM has not responded to a request for comment on the details of its investigation.

The first-in-human trial of Bial’s FAAH (fatty acid amide hydrolase) inhibitor, known as BIA 10-2474, involved 128 healthy volunteers, 90 of whom received different doses of the drug. The six subjects who were hospitalized received higher doses of the drug than the others, and the first subject became ill on 10 January. One day later, contract research organization Biotrial halted the study.

Catherine Hill, an expert in clinical-trial design and a former member of the scientific advisory board of ANSM, told Nature: "The French authorities have not been very rapid nor transparent in their response.”

One of the hospitalized patients has since been discharged, according to Nature, which also notes that the four others are in serious but stable condition. 

ANSM Statement (French)

Rennes, France Hospital Statement (French)