Guidance for progression from the conduct of non-clinical studies to clinical trials for investigational medicinal products in humans are addressed in ICH M3(R2) as well as in the EMA ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’ published in 2007. The EMA guideline mainly addresses the non-clinical aspects of drug development and reflects the practice at the time it was developed which focused on a single ascending dose design for first-in-human (FIH) trials. Since then, integration of the non-clinical data available before FIH administrations and the PK, PD and human safety data emerging during a trial has evolved. Consequently, many FIH trials are now performed with integrated protocols potentially combining different study parts. This concept paper outlines aspects to be considered in revising the current guideline to address the evolution of FIH clinical trials protocols.


Posted on the EMA website on 21 July 2016