Abstract
The lack of harmonization of legislation, guidance and procedures for conducting clinical trials in Europe is generally considered unsatisfactory, despite the implementation of the Clinical Trials Directive in 2004. This article outlines the measures being taken by the Clinical Trials Facilitation Group of the Heads of Medicines Agencies and the Ad Hoc Clinical Trials Group of the European Commission to improve authorization, amendment and safety monitoring for clinical trials. It also comments, from a UK perspective, on the current status of the Commission’s consultation and impact assessment on potential changes to the Clinical Trials Directive, and anticipates the likely changes in the next 5 years.
Acknowledgements
The author would like to thank Professor Kent Woods, Chief Executive of the Medicines and Healthcare products Regulatory Agency, for reviewing this article and providing helpful comments and Katrice Pearce for assistance in preparing the manuscript.
Financial & competing interests disclosure
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.