Ukraine. Clinical Trials System Overview

INTRODUCTION

Ukraine is a post-soviet country which remained closed off to foreign visitors and companies for a long period of time. In the wake of the wellknown political events following the fall of the Berlin wall, the post-soviet countries, including Ukraine, proved to be a fertile ground for explosive market development in many fields, including medicine and pharmacy. Clinical trials (CT) continue to be regarded as a comparatively new and developing sector of the Ukrainian market, despite the fact that the first CTs performed in the country date back to 1996. The market in clinical trials is still there to be won for foreign pharmaceutical companies – in 2009 alone, there were 466 clinical studies initiated in Ukraine – and, while it accounts for a much lower percentage when compared to other countries, many experts nevertheless consider Ukraine to be a country with major potential for market development.

In this article, we take a look at the current state of the CT market in Ukraine, the advantages and disadvantages the country has to offer, as well as who the major players on this market are, and whether there are competent organizations within the country that clients can rely on.

The move towards Central and Eastern European countries

Clinical trials of new drugs are now widespread all over the world and a tendency towards saturation has already been observed in many countries where CTs have been being performed for a long time. The market in such countries has seen a drop-off not only in terms of quantity (significant decrease in the number of treatment-naïve patients, saturation of bases), but in terms of quality as well (fall in number of cases necessary for CT, for example, less patients in the last stages of cancer). Yet the world market still continues to grow, and so do its requirements. Population limitations mean it is not possible to transfer the majority of CTs to African and Asian countries – the organisms of people from such countries may have different reactions to those of their European counterparts. For reasons of geographical proximity, people swiftly turned their attention to the Eastern European and CIS countries.

The region is comparatively new territory for the CT market and undoubtedly has huge potential for growth. It offers a large pool of patients, concentrated into a smaller number of hospitals
than in the West (meaning faster enrollment), physicians with a good enough background to work as principal investigators, as well as the undeniable cost benefits. Experts consider that enormous progress has now been made in the region and that many medical institutions there are now comparable to Western institutions when it comes to offering the infrastructure necessary for clinical research. Of course, that is not to say there are no disadvantages: there are, but they are ones which can be resolved. One such disadvantage, often noted by CT specialists, is the lengthy procedure for the submittal and approval of CT project-specific documents to national committees and ethics boards. But the time lost on such procedures is fully compensated for by fast patient enrollment, meaning that the total time required for a CT project is comparable to that required for the same project in other regions and countries.

Of the CIS countries, Russia was one of the first markets to attract investors’ attention after the borders opened. This was the case for a number of obvious reasons – including being the world’s biggest country by surface area, its large population (142 mln people), as well as the image of Russia on the world stage, etc. Furthermore, international companies are now saying that CTs conducted in Russia generate less complaints than for the same trials performed in other countries; while in Russia patients more rarely drop out of studies than in other countries. In 2008, there were approximately 55 CROs operating in Russia, with around 1000 CTs initiated during the period
from 2004-2007, then 618 in 2008 and 577 in 2009. Most trials are conducted in the fields of oncology, cardiology, neurology, endocrinology and psychiatry.

The next most attractive country for investors in the CIS countries (after Russia) is Ukraine, which has its own specificities, as well as offering at least as much potential as Russia, if not more. In most cases, it is actually cheaper to conduct clinical studies in Ukraine than in Russia, at least when it comes to logistics costs. But, before entering the market, potential clients need to familiarize themselves with the specificities of the country, whether they be of major or more minor importance.

Source: www.centrallab.synevo.eu