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International Clinical Trials

Going Further East in CEE

Many countries in the former Soviet Union have untapped potential for clinical research. Anna Anokhina and Dmitry Meshkov of MB Quest Inc examine recent developments in Eastern Europe

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.


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Anna Anokhina is Head of Regulatory for MB Quest Inc, a member of the Pharm-Olam International Group operating in Russia, Ukraine, Belarus and Georgia. Before joining MB Quest, Anokhina participated in primary health development and preventive healthcare services projects funded by the EU under the Tacis programme. Her degrees include a Master of Nursing Administration and Master of Public Health Management from Moscow Medical Academy. Anokhina is an active member of Sigma Theta Tau International Honor Society of Nursing.

Dmitry Meshkov is Medical Director of MB Quest Inc. Before joining MB Quest, Dmitry was an investigator at Moscow’s Institute for Biomedical Problems, where he received awards from the Committee for Space Research and NASA in recognition of his achievements in the pharmacotherapy of immune depression and allergic reactions in humans under extreme environmental conditions, as well as his management of international space research programmes.

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Anna Anokhina
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Dmitry Meshkov
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