Biotrial Says Will Continue To Cooperate As French Probe Manslaughter Angle in Phase I Case
French prosecutors are beginning judicial proceedings into possible manslaughter following the Phase I trial tragedy in January this year, although CRO Biotrial says the move is "a normal decision" in a complex investigation.
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The French health ministry has given Biotrial, the CRO that ran the disastrous Phase I FAAH inhibitor study in Rennes, one month in which to draw up an action plan to ensure that the "major failings" seen in the trial "cannot happen again." If it fails to do so it may lose its authorization to conduct clinical trials.
French regulator ANSM is under scrutiny following a visit by police investigating the tragic Phase I FAAH inhibitor study, and confirms that it carried out an "internal investigation" whose results have been passed to police and the social affairs inspectorate.
A lower first dose boosted the vaccine’s efficacy result, but AstraZeneca has conceded that this has to be proven in a separate trial. In the meantime, the UK government has asked the regulator to assess the vaccine under a special health emergency provision.