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

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Current effective version

Revision 1 - Adopted guideline

Reference numberEMEA/CHMP/SWP/28367/07 Rev. 1
Published25/07/2017
Effective from01/02/2018
KeywordsFirst-in-human, phase I, early clinical trials, investigational medicinal product, risk mitigation, integrated protocols, multiple ascending dose, dose escalation
Description

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).


Document history

Revision 1

Current version

 

Adopted guideline
 

Overview of comments

 

Draft guideline
 

Concept paper

 

Overview of comments

In operation: 01/02/2018-present

 

Published: 27/09/2017

 

Published: 15/11/2016
 

Published: 21/07/2016

 

Published: 27/09/2017

First version

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/09/2007-01/02/2018


Published: 03/05/2007


Published: 22/03/2007


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