Phase I Trials: French Body Urges Transparency, Says Don't Just Follow The Rules
This article was originally published in SRA
The French committee looking into the devastating failure of the Phase I study with Bial's experimental FAAH inhibitor BIA 10-2474 has called for an international debate on whether data from first-in-human trials of new drugs should be made publicly accessible in order to better protect volunteers taking part in such studies1.
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The European Medicines Agency has put out for consultation a draft revised guideline intended to minimize the risks involved with running first-in-human and other early clinical trials, taking into account the lessons learnt from the French Phase I trial tragedy at the beginning of 2016.
Bial-Portela's drug had 'unique toxicity' not found with other compounds in the class, FDA says; findings could allow studies of Janssen's and Pfizer's investigational FAAH inhibitors that have been on hold to proceed.
Better Risk Assessment And Dose Determination Key To EMA's Plans For Updated Phase I Trial Guideline
Proposed revisions to the European Medicines Agency's guideline on first-in-human studies are intended to help identify and reduce the risks to study participants by making better use of non-clinical data in areas like the choice of the therapeutic dose, the dose escalation strategy, and the criteria for stopping a trial.