The Clinical Trials Directive: How Is It Affecting Europe's Noncommercial Research?

In this article, we examine and discuss the current situation for noncommercial clinical trials in Europe—two years after a new legal framework entered into force. The Clinical Trials Directive, issued in 2001 [1], sought to regulate clinical research in a uniform way across Europe. The basic aims underpinning its development were to cut red tape, speed up research and development, enhance the quality of investigational drugs, harmonise procedures, increase the transparency of the clinical research process, and last, but not least, enforce patient protection. The Directive required that trialists and sponsors ensure ethical review and authorisation by competent national authorities before enrolling participants, drug manufacture in line with Good Manufacturing Practice guidelines, and rigorous observance of the Good Clinical Practice (GCP) principles during the conduct of the trial. Furthermore, the Directive required that any changes related to the execution of the clinical study, and its final results, be reported to the supervising authorities. To transpose the Directive into national law, each European Union (EU) member state has had to change its established legal framework for clinical drug research to meet the requirements of the Directive. Since that time, the Directive has fundamentally changed the face of clinical research in Europe. While the pharmaceutical industry has become accustomed to intervening early in political decisionmaking and legislative processes, public and academic research institutions have taken more time to develop a common action plan in response to the Directive [2,3]. Perhaps due to the legal complexity of the subject, responses to the Directive’s impact on noncommercial research have been limited to surveys [4,5]. Attempts to convey the current situation in the EU are restricted by language and information barriers and by insufficient resources for conducting a Europe-wide analysis.