Going Further East in CEE

Driven by the search for patients for clinical trials, skilled investigators and increasing budget pressures, clinical research expanded rapidly in Central and Eastern Europe (CEE) in the mid 1990s. Pharmaceutical sponsors found these emerging markets enrolled patients quickly and were often more compliant than those in the US and Western Europe. As the number of and interest in trials in CEE grew, sponsors began to investigate the potential for research in countries of the former Soviet Union including Russia, Ukraine, Belarus and Georgia. Initially the focus of this region was as supplemental enrolment for studies where the recruitment of patients was lower than expected. The quality of data in these studies was high and verified by corporate audits and FDA inspections (1).

While CEE still holds significant advantages for research, the region’s popularity continues to grow – increasing the number of competing studies. Finding the required number of patients that fit the inclusion criteria can be challenging for many sponsors, especially for larger Phase III studies. Looking further East to countries of the former Soviet Union can give sponsors advantages in patient recruitment and retention.

This article describes the existing status of clinical studies in CEE and assesses the mechanisms and perspectives supporting further development of clinical studies by reviewing the demographics, availability of experienced investigators capable of conducting industry-sponsored clinical research, the history of trials, and regulatory procedures.

Comparative data on patient populations indicates that the largest countries involved in clinical research in the territory of former Soviet Union (that is, Russia, Ukraine, Kazakhstan, Belarus and Georgia) have a combined population of more than 220 million people – more than Western Europe and comparable with the US (see Table 1). The area spreads across 11 time zones from the Pacific Ocean in the East to the Baltic Sea in the West. The vast territory does not significantly affect the population’s access to clinical sites because the majority of people live in highly concentrated urban areas.

Initially, clinical research in Russia was based in Moscow – the most highly populated city in Europe, with a metro area population of 13.4 million. Moscow’s population density is also the highest in Russia, estimated at 6,232 people per km2 (compared to that of New York, at 1,081 people per km2) (2). It is supported by a large public transportation system that includes: five airports, nine rail terminals and the world’s busiest metro subway system (3). Together with Russia’s second largest city, St Petersburg (5.3 million), the patient pool nears almost 20 million people in only two cities.