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French drug trial had three major failings, says initial report

BMJ 2016; 352 doi: (Published 08 February 2016) Cite this as: BMJ 2016;352:i784
  1. Nigel Hawkes
  1. 1London

Three major shortcomings have been identified in the drug trial that led to the death of a volunteer last month, the French health minister, Marisol Touraine, has said.

Administration of the drug being tested continued even after the first volunteer had fallen ill, Touraine said at a press conference on 4 February. This man, believed to be a 49 year old singer and artist from Brittany called Guillaume Molinet, had been given a dose of the drug on 7 January and admitted to hospital on the evening of 10 January. But on the morning of 11 January Biotrial, the French company carrying out the trial, administered the same dose to five more participants.

The second error was not to inform these volunteers of what had happened the previous evening, to give them the chance to withdraw their consent.

The third had been not reporting the incident to the French national medicines safety agency (ANSM) until four days after the first volunteer had been admitted to hospital.

Touraine’s comments were based on a preliminary report from the French social affairs inspectorate (Inspection Générale des Affaires Sociales), …

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