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), now known as the Clinical Trials Coordination Group.
Keywords: First-in-human, phase I, early clinical trials, investigational medicinal product, risk mitigation, integrated protocols, multiple ascending dose, dose escalation
Current effective version
Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products - Revision 1
Document history - Revision 1 (current version)
Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products - Revision 1
Overview of comments received on 'Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products'
Draft guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products - Revision 1
Concept paper on the revision of the 'Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products' - Revision 1
Overview of comments on 'Concept paper on the revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’
Document history - First version
Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products - First version
Overview of comments received on the draft guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products - First version
Draft guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products - First version