Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products - Scientific guideline
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
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Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products - Revision 1 (PDF/227.76 KB)
Adopted
First published: 25/07/2017
Last updated: 25/07/2017
Legal effective date: 01/02/2018
EMEA/CHMP/SWP/28367/07 Rev. 1 -
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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' (PDF/2.92 MB)
First published: 27/09/2017
Last updated: 27/09/2017
EMA/CHMP/853503/2016 -
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Draft guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products - Revision 1 (PDF/245.48 KB)
Draft: consultation closed
First published: 15/11/2016
Last updated: 15/11/2016
Consultation dates: 15/11/2016 to 28/02/2017
EMEA/CHMP/SWP/28367/07 Rev. 1 -
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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 (PDF/92.31 KB)
Draft: consultation closed
First published: 21/07/2016
Last updated: 21/07/2016
Consultation dates: 21/07/2016 to 30/09/2016
EMA/CHMP/446302/2016 -
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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’ (PDF/642.3 KB)
First published: 27/09/2017
Last updated: 27/09/2017
EMA/CHMP/510967/2016
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Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products - First version (PDF/82.96 KB)
Adopted
First published: 19/07/2007
Last updated: 19/07/2007
Legal effective date: 01/09/2007
EMEA/CHMP/SWP/28367/07 -
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Overview of comments received on the draft guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products - First version (PDF/860.13 KB)
First published: 03/05/2007
Last updated: 03/05/2007
EMEA/295190/2007 Corr. -
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Draft guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products - First version (PDF/153.77 KB)
Draft: consultation closed
First published: 22/03/2007
Last updated: 22/03/2007
EMEA/CHMP/SWP/28367/2007 Corr.