A clinical trial disaster in France results in injuries and death
Cause of problem is currently unknown
One man died and five others were seriously injured in January 2016 after they participated in a Phase I clinical trial in France. The trial assessed healthy individuals’ responses to an FAAH enzyme inhibitor drug for treating mood and anxiety disorders. The man who died had been pronounced brain dead, according to Bial, the Portugal-based pharmaceutical company conducting the research.
The clinical trial began in June 2015 and through January had enrolled 116 volunteers. Eighty-four volunteers were administered the experimental compound. There were no severe or moderate adverse events reported until Jan. 11, 2016. One of the study volunteers died on Jan. 17, according to a Bial news release.
Bial stopped administering the study drug immediately, and as of late January, one of the six volunteers had returned home. At press time, three others remained hospitalized with physicians predicting full recovery, according to Bial.
Bial is working with French health officials to identify the cause of the problem. The company reports that the pre-clinical studies suggested the drug was safe for humans and that the study was approved by French regulatory authorities and the French Ethics Committee.
This was the second time in a decade in which healthy Phase I volunteers experienced serious reactions to a trial drug: Great Britain also had a Phase I drug trial disaster in March 2006 when an immunomodulatory drug called TGN1412 sent six healthy volunteers into intensive care, where they received organ support. No one died, but one of the sickened volunteers remained hospitalized for six months and had multiple organ failure. (See story about British trial disaster in the May 2006 issue of IRB Advisor.)
IRB Advisor will look at the investigation of the French clinical trial disaster, as well as how IRBs and the U.S. research community can prevent such clinical trial disasters in the April 2016 issue.
One man died and five others were seriously injured in January 2016 after they participated in a Phase I clinical trial in France.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.