Reforming the EU environment for clinical trials: what are the challenges?

Abstract

Clinical trials are essential as part of the introduction and evaluation of new medicines and devices. Within Europe large scale trials are increasingly international involving two or more European countries and participants from outside the European Union (EU). Historically, EU countries had individual and varying approaches to clinical trial regulations. The introduction of the Clinical Trials Directive by the European Commission in 2004 intended to harmonize authorization procedures on clinical trials on medicinal products and to improve the generation of reliable patient data; though it has good intentions, it has been controversial in practice. It is important now to re-emphasize the long-standing concerns about the 2004 Directive, because the EU authorities are currently reforming the framework via a Clinical Trials Regulation and because any changes will have an impact on trials nationally and internationally. Prior to implementation of the original Directive, the Federation of European Academies of Medicine (FEAM) welcomed the potential benefits for new drug development and improved medical care that could result, but predicted that problems would occur with an inflexible application to academic investigator-driven non-commercial trials. FEAM, founded in 1993 with the objective of promoting cooperation between national Academies of Medicine, exercises a policy advisory role at the EU level and is now well placed to draw on experience in medical research in many countries and therapeutic areas. The initial concerns expressed by FEAM about the Clinical Trials Directive have been substantiated in the period since its introduction. The negative impact has been compounded by variable implementation across the EU, leading to inconsistencies and lack of clarity in standards and practice. FEAM collected evidence and perspectives with the objective of stimulating debate and informing legislative proposals for reform. Based on this in-depth analysis, the contributors to the FEAM Statement1 were clear that the Clinical Trials Directive …