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French Trial Tragedy May Spark Change In EU Phase I Risk Assessments 

This article was originally published in SRA

Executive Summary

Drug regulators in the EU are looking closely at the way that Phase I studies are planned and designed amid calls for better protection for volunteers in the wake of the French BIA 10-2474 trial tragedy. Among topics likely to be under consideration are a more consistent approach to determining the potential risk of novel compounds, and greater use of sequential dosing in first-in-human clinical trials.