EMA First-In-Human Trial Proposals Focus On Dosing, Non-Clinical Data, Study Design
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.
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The European Medicines Agency has updated its 2007 guideline on the strategies drug sponsors should apply to identify and mitigate risks in first-in-human trials to provide additional advice on dosing issues and the use of integrated protocols, among other things. The revised guideline will apply from February 2018.
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.
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.