The European Union (EU) will have two new member states next month: Romania and Bulgaria. Both countries are ready to implement the EU Clinical Trials Directive, but their membership may have broader implications for clinical research than just harmonized regulations.
Fast patient recruitment - one of the biggest drug development bottlenecks in the West - has been Eastern Europe’s trump card. Clinical trials that take only weeks to recruit patients for in Eastern Europe can take months or even a year in Western Europe.
The major difference between Western and Eastern Europe is the structure of their respective healthcare systems. Eastern European countries have very large hospitals, each dedicated to one therapeutic area where all patients with that disease go to seek treatment. These countries also only have one national healthcare system in which all patients are identified...
It’s not unusual for patient visits for a clinical trial conducted in Eastern Europe to begin within a week of site initiation. But, if Poland’s accession to the EU is any guide, Romania and Bulgaria will need to be careful if they want to avoid some of the pitfalls associated with EU membership.
Poland has suffered a bit of “brain drain,” leaving some medical departments almost deserted by doctors who have emigrated to the UK or some of the Nordic countries. Doctors make very poor salaries in Poland and those who have English fluency and can find employment in the West leave to improve their lot. This means the doctors who are left behind are busier and have less time to conduct clinical trials.
The governments of Romania and Bulgaria will need to consider raising physician salaries to keep them in the country and to continue attracting clinical research funds. These funds are an important contribution to their hospitals’ budgets. Competition for physicians to conduct clinical trials could increase.
Competition for patients for clinical trials could also increase. Countries that accede to the EU must provide a private healthcare system, which could siphon off many of the patients normally funneled in the government-funded centralized healthcare system. With top doctors leaving Romania and Bulgaria for the West and patients opting for private healthcare, enrollment timelines could begin to resemble the West’s. But most feel that in the short term, this scenario is unlikely. Ten or so years down the road, it may be another story.
Aside from fast patient recruitment, Romania and Bulgaria also offer an excellent technology infrastructure. Investment in technology in both countries has been a priority in recent years, and both physician investigators and other clinical research personnel there are adept at using electronic data capture (EDC) and are willing to embrace new technolog. This is an important advantage for countries that want to participate in global clinical trial programs.
How each country handles EU membership will be watched closely by other Eastern European countries that have applied—Croatia, Serbia and Montenegro, which became officially independent from Serbia in June.
In the short term, there should be very few differences, outside procedural ones, in conducting clinical research in Romania and Bulgaria after accession to the EU. But their respective governments would be wise to invest in their physicians for the long term so that they preserve the advantages they offer for conducting clinical research.