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The European Medicine Agency’s new guideline focuses on a sponsor’s responsibility to define the uncertainty associated with the medicines tested in clinical trials. The announcement occurred last week and the EMA guideline will go into effect on January 2nd of 2018. EMA worked with the European Commission as well as representatives of the Member of the European Union through the EU Clinical Trials Facilitation Group (CTFG) to create the guidance.
The revised EMA guideline extends existing EU guidance to address first-in-human (FIH) and early phase clinical trials (CTs) with integrated protocols. EMA stated that “the guideline now refers specifically to the calculation of the starting dose to be used in humans, the subsequent dose escalations and the criteria for a maximum dose- in order to mitigate and manage risks for trial participants.”1
EMA also explained how the “guidance is also provided on criteria to stop a study, the rolling review of emerging data with special reference to safety information for trial participants, and the handling of adverse events in relation to stopping rules and rules guiding process to the next dosing level.”1
The guideline strongly emphasizes the responsibility of the sponsor to define the uncertainty associated with the medicine at every step as well as describing potential risks that might arise.
The concept paper on first-in-human clinical trials was created following the French Phase I trial involving the death of a volunteer in January of 2016. More recently, in the Biotrial-run clinical trial of Bial Laboratory’s molecule BIA 10-2474, there was controversy on the extent of the dosing.
Not only do the revised guidelines refer specifically to dosing, EMA also took into consideration comments received during the public consultation period and workshop in March.
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