The Clinical Trial Facilitation Group (CTFG) has issued a 'Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials' (publication date: 12 February 2019).
This document provides recommendations for sponsors regarding the authorisation and conduct of complex clinical trials. It 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.