Jcs western eastern europe

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Market Report

Market Report

Western Eastern Europe – Another Region on a Global Map of International Clinical Trials The region of Central and Eastern Europe (CEE) entered international clinical trials (CT) about 20 years ago, and now it plays an important role in the clinical trial market, providing up to 9-10% of global enrolment. The CEE region includes more than 20 post-communist countries and has a population of more than 340 million people. Eleven of these countries have already joined the European Union (EU). At the same time the region is not homogeneous. The countries are different not only in languages but also in living standards, access of their population to healthcare institutions, coverage of modern diagnostics and treatment, etc. Based on our 17-year experience in CT in the region we propose dividing CEE countries into three groups. These groups have similarities in terms of high patient and investigators’ motivation to participate in CT, but are different in terms of the possibility of enrolling different target populations. One of these three groups is evidently and fairly quickly drifting towards the treatment and research standards of Western European countries, getting more and more capable of successfully contributing to trials which require modern technologies and highest diagnostic and treatment standards, and this allows us to define CT countries like the Czech Republic, Estonia, Hungary, Poland, Slovakia, and Slovenia as Western Eastern Europe. CEE Region in Clinical Trials Following the fall of the Iron Curtain towards the end of the 1980s, CEE countries including post-Soviet states (altogether more than 20 countries) were exposed to a growing demand among pharmaceutical companies eager to conduct CTs. The CEE region’ population of 340 million citizens is comparable with the USA or Western Europe (WE) 1 . The countries adopted ICH-GCP standards during the 1990s along with the USA and WE 2 . 11 CEE countries have joined the EU: Poland, the Czech Republic, Hungary, Bulgaria, Slovakia, Romania, Latvia, Lithuania, Estonia, and Slovenia (Croatia will finally become an EU member in 2013). Their membership made them integrate their legislation into the European legal framework, including the area covering clinical trials. Gradually CEE countries have become a rather traditional place for CT. There are a number of reasons behind the growing demand for these countries. Most of them inherited centralised healthcare systems. Historically, most have a limited number of specialised medical centres that enable substantial concentration of patients. The physicians and nurses in CEE countries 42 Journal for Clinical Studies

are well-educated 3 . Both community-owned and private clinics in these countries are able to enroll whenever needed not only pretreated but also treatment-naïve subjects, while WE in many cases provides the same “recycled” pool of patients who often are already rather treatment-resistant 2 . The existing vertical referral system in these countries provides only minimal competition (if any) for patients among medical centres. Available access to life-long medical records of patients enables lower rates of screening failures and premature withdrawals 1,2 . Figure 1: Availability of patient population

Further on, the region generally has a growing population migration rate but it is still much lower compared with WE, which enables better long-term follow-up 4 . Finally, it is important to point out that average site productivity in the region is often twice as high as in WE and the USA 2 . A further interesting feature of the region is the fact that, contrary to other regions, clinical research professionals frequently have medical or pharmaceutical education 5 . Most of these countries already own up-to-date diagnostic and treatment facilities, including fusion imaging machines, genetic diagnostics and modern electronic data collection means. Usually CEE countries deal with Phase II and III CTs, in which the region provides a large pool of patients. The most represented areas of CT are oncology, cardiology, rheumatology, hypertension and neurology 6 . It is important to stress that the necessity to translate study documents for submission into local languages should be noted. En masse clinical research professionals in the whole CEE region are either medical doctors, or pharmacists, or hold scientific degrees, which is perceived as a highly desired merit, enabling better and more efficient understanding of the study assumptions and methodology. Volume 5 Issue 2

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Journal for Clinical Studies 41


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