Clinical trials & pharmaceutical research in Europe

European Trials

The population of Western Europe is 400 million (EU-15 - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, the United Kingdom - plus Switzerland, Norway, and Iceland), with considerable immigrant populations from Asia and North Africa.

Clinical research is governed by the 2004 EU Directive. Each member country has its own clinical research infrastructure. The main aim of the Directive is to simplify and harmonise the administrative processes governing clinical trials, allowing mutual recognition amongst countries. However implementation has varied between countries, with some still adapting to the Directive’s standards.

The advantages of setting up clinical research sites in Europe include:

• First world standard of medical practice with high-quality physicians
• Good access to large numbers of patients in key centres
• Shorter study protocol approval time than the US
• Viable, well-funded market of 400+ million people
• Good infrastructure for clinical trial processes & technology
• Reasonable site & CRO costs, somewhat less than the US
• Quality data to ICH-GCP and FDA standards

It is common for US, Canadian and European device companies to conduct their first clinical studies in Europe to obtain a CE Mark, and then conduct US/Canadian clinical trials and regulatory submissions following this recognition.

Europe has a strong pharmaceutical tradition with several international companies headquartered in member countries including Sanofi-Aventis, GSK, AstraZeneca, Novartis, Roche, Boehringer-Ingelheim and Bayer, together with a growing biotechnology sector.

"Australia has been ranked the number one location to conduct pharmaceutical clinical trials"

- Economist Intelligence Unit