The trial has been put on hold and all the volunteers have been recalled.
Six participants of a clinical drug trial have been hospitalized in the northwest of France yesterday. One of them is in intensive care and has been pronounced brain dead.
The six previously healthy individuals were volunteering in a First-in-Man (FIM) study at a privately licensed laboratory in Rennes, France. FIM studies, also known as Phase I clinical trials, are the first of three stages of drug testing on human subjects. At this time, it is not clear which drug was being tested.
Biotrial, the drug-evaluation company running the tests, issued a brief statement today in which they maintain that the “trial has been conducted in full compliance with the international regulations” and that “the priority at Biotrial remains the safety of our subjects.”
The drug trial has been officially put on hold and all the volunteers who have participated are being recalled. The MSNA, France’s regulatory agency for drug safety, will be conducting an investigation at the Rennes laboratory where the trials were held.
In a statement made in French this morning by the Ministry of Social Affairs, Health and Women’s Rights, officials describe the event as a “serious accident,” and the French minister, Marisol Touraine, will be travelling to Rennes today to hold a press briefing.
Serious reactions to drugs in clinical trials are uncommon. In order to be approved for human testing, the drug must be tested for toxicity in animals, usually mice, and cultured human cells. If it passes preclinical testing, a drug must undergo three or more stages of clinical testing in humans.
Phase I: Typically a small number of subjects (20-100) to test safety and dosage.
Phase II: Up to several hundred subjects to test side effects and efficacy (how well it treats the disease).
Phase III: 300 to 3,000 subjects, testing for adverse reactions and efficacy.
The drug being tested in Rennes was in Phase I, meaning that researchers had detailed information on how the drug acts on human cells and in animals, but they needed to test whether it was in fact safe for human use. This process poses a low risk to study volunteers and 70 percent of drugs proceed to the next phase of testing. Every drug in your local pharmacy has undergone these trials to ensure it is absolutely safe and effective to use.