The laudable aims of the European Clinical Trials Directive (EU 2001/20/EC) were to improve the safety and efficiency of both commercial and investigator driven clinical trials and to provide the basis for improved European competitiveness. Unfortunately, even before the directive was finalised, concerns were voiced about potential adverse effects on studies designed to test and implement scientific discoveries in clinical practice (translational research) in Europe.1 2 Today, five years after implementation, evidence shows that the directive has had a negative effect on translational research.

The directive was designed to optimise patient safety, increase the numbers of patients entered into clinical trials, improve the efficiency of trial implementation, ensure best practice in ethical review and regulatory procedures, and harmonise these procedures across Europe. In fact, the implementation of the directive by individual EU member states has caused legislative differences between the different nations and obstacles to the conduct of clinical trials.3 Although practice has improved in some areas of Europe,4 in general the regulatory requirements are highly demanding and expensive, irrespective of the level …