The European Medicines Agency has released for public consultation a draft guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.
This is the first revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’. The revision is intended to further assist sponsors in the transition from non-clinical to early clinical development and identifies factors influencing risk for new investigational medicinal products. The document includes considerations on quality aspects, non-clinical and clinical testing strategies and designs for first-in-human clinical trials (CTs) and early phase CTs. Strategies for mitigating and managing risks are given, including principles on the calculation of the starting dose to be used in humans, the subsequent dose escalation, the criteria for maximum dose and the conduct of the CT including the conduct of multiple parts.
The document open for consultation is available by clicking here.
Comments should be provided using this template. The completed comments form should be sent to FIH-rev@ema.europa.eu.
Please note that the deadline for comments is 28 February 2017.
For more information on the European regulatory system for medicines, please consult this brochure.
