Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

This document addresses non-clinical and clinical issues for consideration prior to the first administration of an investigational medicinal product in humans. It also addresses the design and conduct of early clinical trials, including trials with integrated protocols. Emphasis is put on defining the uncertainty associated with the medicine tested at each step of the development and describing how the potential risks that might arise from this uncertainty will be addressed. The revision was made in cooperation with the EU Clinical Trials Facilitation Group (CTFG).

Keywords: First-in-human, phase I, early clinical trials, investigational medicinal product, risk mitigation, integrated protocols, multiple ascending dose, dose escalation