This document provides recommendations for sponsors regarding the authorisation and conduct of complex clinical trials. The document describes the current perspective of the Clinical Trials Facilitation and Co-Ordination Group (CTFG) on these trials and outlines the major issues that sponsors should address in the process of initiating and conducting complex clinical trials in the EU/EEA.
The document highlights differences between complex clinical trials and conventional clinical trials particularly with regard to clinical trial applications (CTAs) and requests for substantial amendments. These recommendations should be read in conjunction with current legislation regulating clinical trials.
Marketing authorisation applications are outside the scope of this guidance.