What we know so far about the clinical trial disaster in France

One person is brain-dead and five more have been hospitalized after a phase I clinical trial in France went horribly wrong. At least three of the patients may suffer irreversible brain damage if they survive, a doctor treating them said today.

The patients were previously healthy volunteers who participated in a study, conducted by Biotrial, a private company in the city of Rennes, to test the tolerability of a candidate drug. French officials haven't announced which drug, and it's not yet clear why many others who participated in the study since it began in July apparently haven’t experienced similarly severe side-effects.

Details about the accident have been slow to emerge. Biotrial, a well-known contract research firm established in 1989, put a one-paragraph notice on its website today that said, without providing details, that during a first-in-man study, "serious adverse events related to the test drug have occurred in some subjects." (A...

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