Clinical Trials on the Bloc

As the size and complexity of clinical trials increases, particularly large Phase III trials, companies developing new therapeutics are recruiting patients in every region of the globe. With trials that need to meet EU standards of efficacy and safety requiring up to 50 or 60 centres for a single trial, European developers have quite naturally looked to the eastern half of their continent to recruit patients and run trials.

In the decade and a half since the collapse of communism, contract research in Central and Eastern European (CEE) countries has developed rapidly, CEE represents, roughly speaking, the former communist bloc, including ex-Yugoslavia and the successor states to the Soviet Union that are part of the European continent. Eight states in CEE joined the European Union in 2004; from north to south, they are Estonia, Latvia, Lithuania, Poland, the Czech Republic, Slovakia, Hungary and Slovenia. Two more countries from the region are slated to join the EU at the beginning of 2007: Romania and Bulgaria. The region also includes the other successor states to Yugoslavia: Croatia, Serbia, Bosnia and Herzegovina, Macedonia and newly independent Montenegro, which separated from Serbia following a referendum held in June 2006. Among this group, Croatia is by far the closest to membership in the EU, with accession likely before the next elections to the European Parliament in mid-2009.

The European successor states to the Soviet Union – Russia, Ukraine, Belarus and Moldova – are generally considered part of CEE. Whilst most of Russia is geographically in northern Asia, the majority of its population is in Europe, and it is a member of key European organisations such as the Council of Europe and the Organization for Security and Cooperation in Europe. Of these four successor states, the Ukraine and Moldova aspire to eventual membership in the EU, but it would seem that both have quite a way to go in adapting their institutions to European standards, to say nothing of implementing the detailed regulations of the acquis communautaire , which is a necessary prelude to membership. Russia does not aspire to EU membership, and Belarus is still waiting on systemic changes.

TALKING ADVANTAGES FOR TRIALS

For medical researchers developing new drugs through clinical trials, working with partners based in CEE has a number of advantages. First, education and training during the communist period built up large cohorts of skilled professionals who remain up-to-date with the latest developments in their therapeutic areas. Investigators and study sites in CEE are now well-versed in GCP guidelines, they respect patients’ rights, and have high ethical and scientific standards.