The Clinical Trial Directive – 2001/20/EC – has been in place for about a decade. In that time the number of drug trials conducted in the EU has fallen by about 25%.(1) Opinion has been divided about the benefits of the directives and various stakeholders in the clinical research community have expressed concerns about the rise in bureaucracy, the increase in costs of running trials and the continuing lack of uniformity in the EU. The call has been for more streamlining which includes taking a proportionate risk based approach to the conduct of trials with more public openness about each trial and the results they produce. Dr Martin Robinson, Executive VP & IAOCR Ambassador focuses on clinical trial standards.