France’s National Agency for Medicines and Health Products Safety (ANSM) has set up a specialist committee as part of its ongoing investigations into the death of a clinical trial volunteer in January this year.
A French man in his 20s was left brain-dead from serious side effects after taking part in the trial of pain and mood disorder medication, BIA 10-2474, for Portuguese pharmaceutical company Bial.
Several other volunteers developed severe neurological problems during the Phase I clinical trial, which took place in Rennes.
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