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French CRO under fire for trial death
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French CRO under fire for trial death

05.02.2016 - It is not yet clear why a man died during a first-in-man clinical trial in January. However, a preliminary report found several “major shortcomings” by responsible CRO Biotrial. However, all regulations were complied with.

The initial shock has faded after one man died in a Phase I clinical trial conducted by Biotrial. The French CRO was tasked to find out whether a potential painkiller med was safe to use. During the trial, one of the volunteers became sick enough to be taken to hospital, where he later died. Following this, Biotrial could have acted more quickly and decisively, French health minister Marisol Touraine said, citing a report by investigators

After the incident, the lab should have stopped the trial immediately, Touraine elaborated. A day after the man was hospitalised, other test subjects were still given the experimental medicine. Also, all volunteers taking part in the trial should have been informed of the incident immediately. And last but not least, the French drug safety agency should have been notified right away – not four days after the hospitalisation, and three days after the termination of the trial. “The event that occurred was serious enough to compromise the safety of the volunteers,” Touraine pointed out.

However, no regulations were breached, the minister continued. According to her, the investigators did not call for a suspension of Biotrial’s authorisation. However, the final results will only become available in late March.  

The drug in question was an FAAH inhibitor developed by Portuguese pharma company Bial. Although there is no indication so far that FAAH inhibitors are unsafe, Janssen has suspended its own phase I trial of a drug with a similar mechanism. Other drug makers are continuing with their own trials, such as Pfizer, which has an FAAH blocker in phase II trials for several indications.

 

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http://www.european-biotechnology-news.com/news/news/2016-01/biotrial-under-fire-for-trial-death.html

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No liability assumed, Date: 07.02.2016