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International Clinical Trials

Research Reaches Beyond Borders

As the growth of clinical research market activity continues, Irina Dobreva of Congenix LLC evaluates Russia and Ukraine’s role in international clinical trials in 2007, and asks what 2008 has in store

Clinical research currently is a highly relevant issue in Russia. Having started its development in the late 1980s, this area of medical activity is now stable and not expected to be subject to drastic reform, as it is based on robust legislation. Russia has by now become internationally acknowledged in the field of clinical research, thanks to the highly qualified physicians and the technical capabilities that promote rapid patient recruitment into clinical trials.

Nevertheless, close monitoring of the clinical research market in Russia highlights the ban on exporting biological samples that ran for two weeks in June 2007 and jeopardised trials conducted there. Those two ‘black’ weeks have undoubtedly had a negative impact on Russia’s rating, although that impact was a short-term one. For instance, according to information from the Russian Ministry of Health, the number of international multicentre clinical trials in Q2 2007 was reduced by 22 per cent when compared with Q2 2006.

However, as early as Q3 2007, the clinical trial market stabilised and 92 clinical trials were permitted by Roszdravnadzor (the public health and social development watchdog agency) to take place in Russia versus 95 in Q3 of the previous years. The total number of international multicentre clinical trials approved in Russia in Q1-3 in 2007 was 236. The distribution of clinical trials in groups of priority indications and phases is presented in Table 1 (1).

In 2007 GlaxoSmithKline, Sanofi-Aventis, AstraZeneca, Hoffmann-La Roche and Bristol-Myers Squibb became frontrunners in Russia in terms of the number of trials, the total number of study sites involved in trials and the total number of patients expected to be randomised (2). As predicted, the quantity of patients falls when related to clinical trials in cardiovascular disease (see Figure 1). The most active therapeutic areas in the number of trials are oncology and endocrinology (see Figure 2).

THE FORMATION OF THE REGULATORY SYSTEM AND ETHICS EXPERTISE IN UKRAINE

The legal procedures for conducting clinical trials in Ukraine are set by the state law ‘On medicinal products’ (1996), which governs how trials should be conducted, and the typical regulations for ethics commissions, approved by the Ukrainian Ministry of Health in 2006. The development of the latter documents took into consideration the requirements of Directive 2001/20/EC (3).


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Irina Dobreva is Chief Executive Officer and co-founder of Congenix LLC, a Russian CRO established in 2004. Irina has extensive experience in clinical trials, not least starting as an expert at the Russian Ministry of Health. Before founding Congenix, Irina was involved in the implementation of several oncology studies in numerous Russian investigational sites for an American CRO. She qualified in Medicine from Ural State Medical University and trained in Oncology. Irina undertook PhD research at Russia’s biggest oncology research centre specialising in breast cancer treatment.
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Irina Dobreva
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