The EMA ‘Guideline on strategies to identify and mitigate risks for first-in-human (FIH) clinical trials (CTs) with investigational medicinal products’ was published in 2007. It mainly addresses the non-clinical aspects of drug development. This reflects the practice at that time which focused on a single ascending dose design. Since then, integration of the non-clinical data available before FIH administrations and the pharmacokinetic, pharmacodynamic 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 revision extends the guidance to early phase CTs including single study or integrated protocol designs.


Posted on the EMA website on 15 November 2016