The BIAL/Biotrial case of death of a human volunteer in the first-in-human study of BIA 10-2474: Are we missing the fundamentals?

@article{FunckBrentano2016TheBC,
  title={The BIAL/Biotrial case of death of a human volunteer in the first-in-human study of BIA 10-2474: Are we missing the fundamentals?},
  author={C. Funck-Brentano and J. M{\'e}nard},
  journal={Presse Medicale},
  year={2016},
  volume={45},
  pages={719-722}
}
The presentation and discussion of the BIAL/Biotrial case below is based on publicly available information [1], [2] and [3]. On Sunday 10 January 2016 in the afternoon, Mr. X., a 49-year-old healthy subject participating to a first-in-human (FIH) study of the nonselective fatty-acid amide hydrolase (FAAH) inhibitor BIA 10-2474 experienced blurred vision and headache. He was one of the six volunteers receiving BIA 10-2474 in the 5th cohort of the multiple ascending dose part of the protocol and… Expand
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References

SHOWING 1-10 OF 15 REFERENCES
Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412.
French drug trial protocol fails to answer key questions
  • N. Hawkes
  • Medicine
  • BMJ : British Medical Journal
  • 2016
FAAH inhibitors in the limelight, but regrettably
Protecting research subjects--the crisis at Johns Hopkins.
Researchers question design of fatal French clinical trial
FAAH (Fatty Acid Amide Hydrolase)
  • on the causes of the accident during a phase 1 clinical trial in Rennes in January 2016. 2016; http://ansm.sante.fr/content/download/88057/1108293/version/1/file/CSST_FAAH_Rapport- Final_Version-Anglaise_18-04-2016.pdf. (Last accessed: 21 August 2016).
  • 2016
Enquête sur des incidents graves survenus dans le cadre de la réalisation d’un essai clinique (Tome 2)
  • Rapport définitif : Observations et réponses des organismes et de la Mission
  • 2016
DGS/PP1/2016/208 du 27 juin 2016 relative à l’organisation d’inspections des lieux de recherches autorisés à conduire des recherches biomédicales
  • (Last accessed:
  • 2016
DGS/PP1/2016/61 du 1er mars 2016 relative aux déclarations des faits nouveaux et des évènements indésirables graves 10 survenant au cours des essais cliniques
  • (Last accessed:
  • 2016
...
1
2
...