From Research to Clinical Application-The Quality Concept

Abstract

For those involved in clinical research in Europe there will be fundamental changes in the way clinical trials are regulated as a consequence of the European Clinical Trials Directive. EU member states have until 1 May 2003 to draw up legislation implementing the Directive, whose purpose is to ensure that quality is a mandatory component of clinical trials. Research sponsor, host institutions and investigators will be responsible for ensuring clinical trials fulfill the requirements of Good Clinical Practice (GCP) and, where studies involve the use of investigational medicinal products (IMP), Good Manufacturing Practice (GMP). The Licensing authorities will act to ensure compliance with standards, which will include performing inspection of trial and manufacturing sites. These changes offer particular challenges to those involved in translational research as the cost and resource implications are likely to be high.