French drug trial had three major failings, says initial report

BMJ 2016;352:i784
Author: Nigel Hawkes
“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. …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.”
Find extract here.