EMA Revises Guideline On First-in-Human Trials

The European Medicines Agency (EMA) has published new guidance on first-in-human clinical trials to help stakeholders identify and mitigate risks for trial participants.

The revision takes into account the fact that in the past 10 years trial protocols have become increasingly complex and now often include different parts within a single clinical trial protocol, aimed at assessing for example single and multiple ascending doses, food interactions, or different age groups, according to the agency.

“The strategies to mitigate and manage risks for trial participants described in the guideline refer specifically to the calculation of the starting dose to be used in humans, the subsequent dose escalations and the criteria for maximum dose,” noted the EMA statement. “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 progress to the next dosing level.”

The revision considered the comments received during a public consultation and a follow-up workshop that took place in March 2017. EMA will make available all comments received, both on the initial concept paper and on the revised guideline, in September 2017.

This guideline was revised in cooperation with the European Commission and the representatives of the Member States of the European Union through the EU Clinical Trials Facilitation Group.

To view the full release, click here.

Philip Ward is the European Editor for Applied Clinical Trials.