Conducting a European multi-center trial: first experiences with the new EU Clinical Trials Directive from an academic perspective

摘要

In 2001 the European Union adopted the EU Clinical Trials Directive (2001/20/EC) as a framework for good management in trials of medicines . Many concerns were expressed that this Directive would impede and inhibit publicly funded clinical trials [2, 7, 14].The question is if the concerns regarding the Clinical Trials Directive were legitimate. In other words, has the Directive really made it practically impossible for a group of surgeons to initiate, organize and conduct a European multi-center study? But also, has the new Directive achieved the goal of simplifying and harmonizing the administrative provisions governing clinical trials in EU countries?As a University Medical Center, we have experienced the practical consequences of the Clinical Trials Directive at first hand during a European multi-center study on instrumented lumbar spinal fusions with the use of OsteogenicProtein-1 (OP-1). The objective of this paper is to provide insight in the difficulties involved while conducting such a Europeanmulti-center study under the new EU Clinical Trials Directive.