An expert group convened by the UK government to review the safety of Phase I trials made 22 recommendations today (July 25) to improve first-in-human studies, responding to an incident last March when six healthy volunteers developed life-threatening side effects during a phase 1 trial of a monoclonal antibody.An investigation of the trial, using the monoclonal antibody TGN1412, attributed blame to an unexpected biological effect of the molecule.Since then, the experts, led by Gordon Duff of Sheffield University, have met six times. Their recommendations focus on calculating and administering first doses, sharing information regarding safety, and giving regulators access to specialist opinion in appraising trial applications for high risk drugs."Clinical trials in general have an excellent safety record, but in the light of the TGN 1412 incident there is a need to look at the future safety of clinical trials involving novel and potentially higher risk drugs," Duff said in...
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