EU Clinical Trials Directive

Do you do clinical research in Europe? How is your company faring since the establishment of the European Union’s Clinical Trials Directive (2001/20/EC)? The Directive, implemented into EU member states legistlation in 2003 and entered into force in 2004, is a document "relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use". It is available in downloadable PDF form online.

Clinical trials in Europe are different than in the USA, and it goes without saying that in order to prevent unnecessary work and loss of money, it's important to be very familiar with the rules wherever you do your research. The EU has 27 member states and, therefore, 27 different sets of rules for GCP in clinical trials, since each member state interprets the Directive differently. The rules for filing SUSARs also differ between countries.

One thing is the same wherever you go: Your clinical trial plan has to be approved by local, regional AND national ethics committees, and individual studies need to be approved, as opposed to individual drugs, which means applying anew for each study with one drug.

Does the directive get in the way of clinical trials in Europe? In August 2005, Fortune magazine reported that 40% of clinical studies have moved to countries like Russia and India, where costs are lower and individuals participating in drug trials are more vulnerable, in the absence of organized ethics legislation or committees, and not aware of their rights, or the risks.

The directive may not be perfect, but is intended to protect citizens and drug trial participants. In a letter to BMJ (Feb. 28, 2004), Francis P. Crawley (Secretary General, European Forum for Good Clinical Practice) says "The upshot of the directive may be that national research is strengthened. The answers to the challenges do not lie in the directive alone. Directive or no directive, the question is how to create a robust European research environment that ensures patient protection and public confidence in all areas of health research."