Saturday, January 16, 2016
Bial's Clinicial Trial in France Ends In Disaster. What Went Wrong?
A Phase 1, or first-in-human clinical trial run by Biotrial, a long-standing French-based clinical research organization, ended disastrously. One healthy volunteer is brain-dead and others are seriously—and perhaps permanently—left with serious neurologic damage, according to Dr. Pierre-Gilles Edan, head of the neurology department at the hospital in Rennes where the volunteers were taken, and France Health Minister Marisol Touraine. Edan said that MRIs of the affected patients show deep cerebral hemorrhage and necrosis and that the "handicap that could be irreversible."