Summary

In July 2017, the European Medicines Agency (EMA) published its revised guidance on first-in-human (FIH) and early clinical trials. The revision provided detailed guidance to identify risks to trial participants arising from uncertainty associated with the medicinal product tested and to mitigate these risks in trial design and conduct. Clinical study protocols address the provisions of the revised guidelines, complying with applicable guidance for protecting the safety and wellbeing of participants and producing strong scientific outcomes. The protocol also provides latitude for justified alternative study design approaches.

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