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.
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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.
New clinical trial rules have been introduced in France covering aspects such as safety reporting for volunteer trials, trial site authorization, and a clearer distinction of trial type in terms of risk level.
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.