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French drug trial protocol fails to answer key questions

BMJ 2016; 352 doi: https://doi.org/10.1136/bmj.i466 (Published 25 January 2016) Cite this as: BMJ 2016;352:i466
  1. Nigel Hawkes
  1. 1London

Details of the drug trial in France in which one man died and others were left with severe health problems have emerged, but there is still no clear evidence of what went wrong.

After Le Figaro published the trial protocol,1 the French national agency for the safety of medicines and health products formally released it. The report revealed the chemical structure of the drug BIA 10-2474, developed by the Portuguese company Bial, and the trial procedure—single administrations of the drug at increasingly higher doses, followed by multiple administrations given on successive days.

Of the six people who …

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