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Thursday, February 4, 2016

French drug trial leaves one brain dead and five critically ill

By Angelique Chrisafis
The Guardian
Originally published January 15, 2916

Here is an excerpt:

Touraine said the study was a phase one clinical trial, in which healthy volunteers take the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”.

Medical trials typically have three phases to assess a new drug or device for safety and effectiveness. Phase one entails a small group of volunteers and focuses only on safety. Phase two and three are progressively larger trials to assess the drug’s effectiveness, although safety remains paramount.

Testing had already been carried out on animals, including chimpanzees, starting in July, Touraine said.

Bial said it was committed to ensuring the wellbeing of test participants and was working with authorities to discover the cause of the injuries, adding that the clinical trial had been approved by French regulators.

The story is here.
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