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Clinical Trials in Russia. 2nd Quarter 2009

On August 24, 2009 Synergy Research Group (SynRG), a Russia-based CRO, presented the English version of SynRG Orange Paper Q2 2009, a regular 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 129 new clinical trials of all types including local and bioequivalence studies during the second quarter of 2009; demonstrating a 17% decrease over the corresponding period of last year.

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 65% of the total number of clinical trials approved by RZN in the second quarter of 2009.

The shares of the local trials and bioequivalence studies in Q2 2009 stood at 21% and 14% of the total number of studies, respectively, while they accounted to 24% and 15% in Q2 2008.

Clinical trials in Russia in Q2 2009 were sponsored by companies from 16 countries. The maximum number of trials (42) were initiated by Russian sponsors, American sponsors with 37 studies took the runner-up place, they are followed by the Swiss sponsors with 13 trials, 12 new trials were instigated by the German manufacturers, UK sponsors with six new studies, and the top six is concluded by the Japan sponsors with four new studies in Q2 2009.

The number of patients which are planned to be enrolled in the Phase II-IV trials launched in the second quarter of 2009 stood at 12,338 patients, nearly the same as the last year number (12,000).

The Swiss Novartis sponsoring 11 new studies is on the top of the heap in the second quarter of 2009. The American Pfizer with eight new trials in Q2 2009 took the runner-up place. It is followed by Bristol-Myers Squibb sponsoring six new studies. The top five is concluded by Eli Lilly and Merck & Co. both having five new studies in Q2 2009.

The Russian pharmaceutical company OAO Valenta Pharmaceutica sponsoring five new clinical trials enrolling 348 patients in 10 sites, ranked number one among domestic pharmaceutical manufacturers by the number of new studies in the second quarter 2009. OAO Biokhimik with three new trials and 54 subjects in three sites, took the runner-up place. It is followed by OOO Lans-Pharm and ZAO Obolenskoe. The top five is concluded by ZAO Biocad.

Seventy five per cent of the new studies in Q2 2009 were conducted in the six leading therapeutic areas. The maximum number of trials (29) were initiated in Cardiovascular diseases; 22 clinical trials in Oncology; 17 new studies in Endocrinology; 12 – in Respiratory diseases; 10 new studies in Infectious Diseases and six new Neurology studies were initiated in Q2 2009.

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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