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Clinical Trials in Russia. Year 2008.
On February 04, 2009 Synergy Research Group (SynRG), a Russia-based CRO, presented the English version of SynRG Orange Paper Year 2008, 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 615 new clinical trials during 2008, a 9% increase over last year’s figure. The main contribution (59%) is made by multinational multi-center clinical trials, though their number decreased by 1.2% over 2007 and stood at 364 new studies in 2008.
Clinical trials in Russia in 2008 were sponsored by the pharmaceutical manufacturers from 36 countries. The maximum number of trials (201) was initiated by Russian sponsors. American sponsors (145 trials) took the runner-up place, they are followed by the German (60) and the UK (43) companies, and the top five is concluded by the Swiss sponsors with 34 new trials.
Thirty eight new Phase I clinical trials were launched in 2008; which is six trials increase over last year. The number of the Phase II trials slightly decreased from 158 trials in 2007 to 152 in 2008. The number of Phase III trials demonstrated the biggest increase, 21% up over last year, from 232 to 282 studies. The number of Phase IV trials slightly increased from 60 in 2007 to 62 in 2008.
More than sixty thousand patients are planned to be enrolled in the Phase I-IV trials instigated in 2008.
The Swiss pharmaceutical giant Novartis sponsoring 22 new studies was on the top of the pile by the number of new trials started in 2008. The French sanofi-aventis instigating 21 new trials in 2008 took the runner-up place, it is followed by the UK GlaxoSmithKline with the maximum number of patients – more than eight thousand.
The Russian Valenta, sponsoring 14 new clinical trials ranked number one among domestic pharmaceutical manufacturers by the number of new studies in 2008. ZAO Biocad with 11 new trials took the runner-up place. It is followed by OAO Sintez which instigated 9 new studies in 2008.
St. Petersburg State Medical University n/a Pavlov ranked number one among the Russian investigative centers by the number of new studies (104) in 2008. Russian Scientific Oncology Center n/a Blokhin with 84 new studies took the runner-up place. It is followed by the St. Petersburg Military Medical Academy n/a Kirov accommodating 78 new trials in 2008.
Almost three-fourth of the new studies in 2008, or 73%, were instigated in the following seven therapeutic areas: Oncology (91); Circulatory System (87); Respiratory System (60); Endocrine and metabolic diseases (57); Musculoskeletal System (54); Infectious diseases (51) and diseases of the Nervous System (50).
As of 12 November 2008, there were 946 hospitals entitled to conduct clinical trials in Russia. Ninety two new sites were designated by the RZN during 2008.
Thirteen FDA inspections were conducted in the Russian investigative sites during 2008: during seven of them no objectionable conditions or practices were found, and six inspections resulted in VAI (Voluntary Action Indicated).
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, with the total area of 180 square meters. Today, Synergy Research Group is represented in Moscow, Saint-Petersburg, Novosibirsk, Yekaterinburg, Perm and Almaty (Kazakhstan). The company’s headquarters are in Moscow.