Abstract

In April 2014, the European Parliament agreed the final text on a new EU Clinical Trials Regulation.1 The Regulation replaces the EU Clinical Trials Directive, which has long been criticised by various stakeholders for creating unnecessary bureaucracy and blamed, at least in part, for increased costs, time delays and a drop in clinical trial applications. The new Regulation seeks to remedy the faults of the previous legislation and make the EU an attractive place to conduct clinical trials.The Regulation aims to streamline and harmonise the administrative procedures for clinical trial approvals but without compromising the safety of participants. A particular focus is placed on the importance of enabling trials in multiple or all member states, recognising that there is an increasing need to target ever more specific patient populations and the challenge this represents in recruiting sufficient numbers of participants to research studies. A new, two-part application process, designed to avoid the multiple submission of identical data is therefore to be introduced. Member states cooperate on certain aspects of trial approval but issues which are subject to specific national regulations will continue to be approved by individual countries. All applications will be submitted through a new EU portal, which will be set up and managed by the European Medicines Agency. The new process also takes a risk-based approach to some types of research study. Trials to test medicinal products that already have a marketing authorisation are classed as ‘low intervention trials’ and are subject to less stringent requirements.The ethical safeguards in the new Regulation remain similar to those in the 2001 Directive. A positive appraisal from a research ethics committee remains a prerequisite for a trial to be approved. Member …