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Clinical Trials in Russia. 3rd Quarter 2009

On August 24, 2009 Synergy Research Group (SynRG), a Russia-based CRO, presented the English version of SynRG Orange Paper Q3 2009, a regular free analytical report on the clinical trial market in Russia. The report contains hundreds of figures as well as dozens of tables and pictures covering various aspects of the Russian clinical trial market. This is another step to formation of a civilized market of clinical trials in Russia and improvement of the research attractiveness of Russia for foreign sponsors, one of the SynRG’s key strategic goals.

The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (alias RosZdravNadzor, RZN) approved 153 new clinical trials of all types including local and bioequivalence studies during the third quarter of 2009; demonstrating a 10% decrease comparing to the last year figure.

The main contribution into the total number of studies is still made by multinational multi-center clinical trials, even though the number of such studies decreased by 5% from Q3 2008 figure and stood at 93 new studies in Q3 2009.

The proportions between different study types (multinational multi-center clinical trials, local studies and bioequivalence trials) did not change significantly over the same point in 2008 and will doubtfully change in the near future. Despite the decrease in the number of studies, the share of multinational multi-center clinical trials slightly increased from last year’s figure and stood at 61% of the total number of clinical trials approved by RZN in the third quarter of 2009.

More than the two thirds of clinical trials in Russia is being sponsored by foreign companies - 67% of the total number of new studies in Q3 2009, almost the same as the last year figure (66%). The maximum number of trials (51) were initiated by Russian sponsors, American sponsors with 30 studies took the runner-up place, they are followed by German sponsors with 14 trials, 12 new trials was instigated by Swiss manufacturers, the UK sponsors with seven new studies, and the top six is concluded by Japan and Danish sponsors each with six new studies in Q3 2009.

Nine new Phase I clinical trials were launched in the third quarter of 2009; one trial less than in the corresponding quarter of last year. The number of the Phase II trials increased by 20%, from 39 trials in the third quarter of 2008 to 47 in the third quarter of 2009. The number of Phase III trials demonstrated a slight decrease from last year number, down from 94 to 86 studies.

The number of patients which are planned to be enrolled in the Phase II-IV trials launched in the third quarter of 2009 stood at 11,956.

The Swiss giant Novartis sponsoring 10 new studies is on the top of the heap in the third quarter of 2009. The Danish top five “debutant” Novo Nordisk with six new trials in Q3 2009 took the runner-up place. It is followed by GlaxoSmithKline sponsoring five new studies, and Merck & Co. with four. The top five is concluded by Eli Lilly having four new studies and fewer patients in Q3 2009.

The Russian pharmaceutical company OAO Ozon sponsoring five new clinical trials ranked number one among domestic pharmaceutical manufacturers by the number of new studies in the third quarter 2009. OAO Canonpharma Production with four new trials took the runner-up place. It is followed by NPO Microgen with three new trials and OAO Sintez with the same number of studies but less patient number. The top five is concluded by OAO Valenta with two new studies.

Synergy Research Group (SynRG™) is a Russian contract research organization, which has been successfully operating in Russia since 2002. SynRG™ offers a broad range of services for conducting clinical trials for Russian and foreign pharmaceutical and biotechnological companies – from registration of the studies in regulatory authorities to pharmaco-economic surveys. The company has its own clinical depot in Moscow. Today, Synergy Research Group is represented in Moscow, Saint-Petersburg, Novosibirsk, Yekaterinburg, Perm, Rostov-on-Don, and also in Almaty and Astana in Kazakhstan. The company’s headquarters are in Moscow.


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