Russia's clinical scene to remain 'heated'

According to research and consulting firm PMR, the clinical trials market in Russia has attracted "considerable interest" in the last 12 months, with 38,000 patients participating in clinical trials in the country and global clinical research organisations (CROs), such as PPD, i3 Research and Chiltern, increasingly opting to set up operations there. A survey recently released by the firm, titled: "Clinical Trials in Russia 2008", indicated that over half (22) of the 40 decision-makers from pharmaceutical companies and CROs active in Russia interviewed "foresaw no change in the good situation in the sector of clinical trials in Russia in 2008​". In addition, 15 respondents said they expected the market climate to "improve even further", with only two companies indicating to the contrary. "It seems market players believe that interest in conducting clinical trials in Russia among foreign companies will remain strong in 2008​", said Monika Stefanczyk, a co-author of the report. "Some companies are counting on the simplification of legal regulations affecting clinical trials and the implementation of international standards such as GCP​". Eastern Europe is increasingly drawing the attention of foreign pharmaceutical investments in the clinical arena, drawn by the relatively low costs and fast recruitment of patients. Countries such as Turkey, Bulgaria, Russia, Romania and the Ukraine are particularly attractive, with the latter three showing the most popularity, according to PMR. All three of these countries have large development potential due to their vast populations (140m in Russia, 46m in Ukraine and 22m in Romania). Russia and the Ukraine in particular, with their 200m population of largely treatment naïve patients - greater than in all 12 Western European countries combined - have become increasingly popular for sponsors and CROs to base themselves in order to conduct clinical development programmes. The countries have a recruitment rate between two and ten times faster as well as a cash saving of up to 50 per cent compared to the best and drug trials from the US have tripled here in the past three years. Of the three, Russia dominates the scene by far, holding one third of the total Central and Eastern European market, but all have experienced extremely intensive growth for the past few years and in 2006, the pharma markets in Russia and the Ukraine increased their value by one third, while the Romanian market grew by one fifth. Indeed, in terms of Russia, from a CRO point of view, the survey indicated that there are "more and more" sponsors interested in conducting clinical trials in the country. As a consequence, there are also more and more CROs offering to organise clinical trials at Russian sites, and the market is correspondingly expanding at an average of 20 per cent year-on-year. As an example of this, in February, PPD announced it would be moving into Russia via the purchase of InnoPharm, another CRO based in Smolensk, which also has offices in Moscow and St Petersburg and a staff of 300. The acquisition of InnoPharm, which offers Phase II-IV clinical trials, data management and biostatistics services, will not only provide PPD with a foothold in the vast clinical territory of Russia, but also in neighbouring Ukraine, where it has an office in Kiev. "With more than 143m people in Russia alone, Eastern Europe is a high-growth market for clinical trials and a region PPD has targeted for expansion​", said Eshelman at the time of the announcement. Eschelman aded: "We will put the accelerator down in Russia as much as we can, there are a lot of opportunities in terms of oncology and the large population… we will take a look at what other offices we are going to open there, we are dealing with 12 different time zones which makes travel difficult for CRAs​". Moreover, in April, i3 Research bought a Russian counterpart, Lege Artis, in a purchase that the firm said will give it "new access to clinical sites and investigators in Russia​", in addition to Belarus and Ukraine, where Lege Artis also has operations. ​"Russia has become a strategic geographic area in the drug development process, with well educated and experienced medical doctors and a vast population of patients who are interested in participating in clinical trials​,​" said i3's CEO Glenn Bilawsky at the time. Around the same time, Chiltern also made its move into Russia, opening a new office in St Petersburg, in a move that Armand Czaplinski, Chiltern´s general manager of Central and Eastern Europe (CEE) described as "a logical next step" in the company´s continued growth in the CEE region. Over the last few years, Chiltern has already been conducting trials in Russia in response to sponsors' requests to involve the country in global studies, but has not yet had a permanent presence. "Today, with an ever-higher number of competing trials, the pharmaceutical industry increasingly recognises the potential of CEE countries to meet enrollment goals​,​" said Czaplinski at the time of the announcement. "The availability of trained staff and the quality of the data produced, has resulted in an increased number of US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) approved clinical trials​.​" Meanwhile, PMR also said that some respondents in its survey said that the quality of research is improving in russia, with clinical trials now being organised "faster and more efficiently​". "Some respondents also mentioned the excellent qualifications of medical staff (researchers) as well as their relevant experience​," the firm said, citing figures that over 60 per cent of Russian clinical investigators have PhD credentials, with 40 per cent of them teaching at major universities.