NYU Langone Medical Center

EMA proposes changes to first-in-human trials spurred by January’s Bial trial deaths

Monday, August 1, 2016

Are the risks faced by phase I clinical trial participants too great? The European Medicines Agency (EMA), the European Commission and the Member States of the European Union (EU) believe so. Together, they’re proposing changes to current guidance on first-in-human clinical trials that would, if successful, improve strategies for identifying and mitigating risks to study subjects.

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