ANSM

Disclosures bring continued focus to Bial trial

Thursday, June 1, 2017

Last year, two issues of Research Practitioner included a discussion about a French trial in which one healthy volunteer died and five others were hospitalized. Researchers and pharmacologists are becoming more critical of the trial as new information become available. Were the researchers negligent? Why was this compound chosen over other similar ones for the study?

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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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