French clinical trial tragedy – dead for EUR1900

Precis A Phase I first in human scientific trial on healthy volunteers, sponsored by Portuguese pharmaceutical company Bial, went badly incorrect in early January 2016, leaving one volunteer dead and five others hospitalised with organ failure and in many cases believed brain damage. Bial was trialling the drug (BIA–– 102474–– 101) for a variety of diseases consisting of mood disorders, anxiety and as an analgesic and had engaged French agreement research organisation BioTrial (the ‘& lsquo; CRO & rsquo;-RRB- to manage the trial. What? The trial, conducted at a single website in France at the private BioTrial Research Site (in Rennes), began on 9 July 2015, like any other trial, after receiving both ANSM and EC approvals to the trial method. The trial prepared to consist of 128 healthy volunteers. The f.
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