The European Medicines Agency (EMA) has revised its guidance on first-in-human clinical trials to further 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.
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. 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 European Patients’ Forum (EPF) has put together a fact-sheet – ‘Putting Patients at the Centre of Clinical Trials’. For further information on clinical trials, the importance of patients and the role of the EU, view the fact-sheet here.
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