Following the death of one and the hospitalizations of other clinical trial subjects, French regulators are moving to strengthen safety measures and bolster the response when trials start to go wrong, ScienceInsider reports.
Earlier this year, the French contract research company Biotrial was testing a drug called BIA 10-2474 developed by a Portuguese pharmaceutical company Bial in a cohort of healthy people when one of the research volunteers was hospitalized with stroke-like symptoms and died a week later. Five other volunteers who had received an additional dose were also hospitalized and four of them had headaches, short-term memory problems, and damage to parts of their brains, as NPR has reported. It adds that an investigation showed that the trial followed established rules, but "lacked common sense."
ScienceInsider says that France's General Inspectorate of Social Affairs (IGAS) has now released a report that asks the government to "mobilize the international scientific community" to figure out what went wrong. At the same time, French health minister Marisol Touraine announced that inspections would be conducted at each of the country's clinical trial centers and the National Agency for Medicines and Health Products Safety would begin to generate monthly reports detailing serious and unexpected side effects reported in phase I and II studies.
In the report, IGAS also questions Biotrial's decision to test a drug of unclear proposed benefit as well as its choice to give volunteers the drug at the same time, rather than on a staggered schedule. Biotrial must submit a "plan of action" describing how it will avoid such mistakes in the future, ScienceInsider adds.