Clinical Trials in Russia, 3rd Quarter 2007
According to SynRG Orange Paper, in the 3rd Quarter 2007, the overall volume of the clinical trials in Russia and its basic parameters are generally the same as in the corresponding quarter of the last year. In the 3rd Quarter 2007 RosZdravNadzor (RZN) has issued 141 approvals for conducting new clinical trials, which is 2% more than in Q3 2006.
According to SynRG Orange Paper, in the 3rd Quarter 2007, the overall volume of the clinical trials in Russia and its basic parameters are generally the same as in the corresponding quarter of the last year. In the 3rd Quarter 2007 RosZdravNadzor (RZN) has issued 141 approvals for conducting new clinical trials, which is 2% more than in Q3 2006. In comparison with the last year the proportion between international clinical trials, local clinical trials and bioequivalence studies remains unchanged.
There is a minor increase in the share of Russian sponsors in the total number of clinical trials which accounts for 31% of the total number of studies initiated during Q3 2007. Among the foreign sponsor countries the majority comes from the United States (30% of clinical trials), Germany (10%) and Great Britain (7%).
An increase in the number of Phase II trials (by 57%) and a decrease of the number of phase III trials (by 18%) is observed. The total number of patients who are planned for recruiting has decreased by 12% (from 16,340 to 14,431), compared with the Q3 2006.
Among foreign sponsors the leader is Bristol-Myers Squibb (7 new studies in 95 sites recruiting 2,033 patients in total), among Russian sponsors – OOO ROZFARM.
Among the therapeutic areas the maximum number of clinical trials have been initiated in oncology (29 studies in 230 sites with total number of 1,784 patients), on the second place are cardiovascular trials (18 trials, 220 sites, 4851 patients), then go studies in nervous system diseases (15 trials in 84 sites recruiting 1,112 patients).
In the 3rd Quarter 2007 the US Food and Drug Administration (FDA) approved 7 new drugs which had been tested in clinical trials conducted on the territory of Russia. European Agency for the Evaluation of Medicinal Products (EMEA) approved 5 marketing applications for drugs which had been tested in clinical trials in Russia.
32 new investigator’s sites in Russia were approved by the RZN for conducting clinical trials, thus the current number of investigative sites in Russia is 800.
Synergy Research Group (SynRG™) is a Russian contract research organization, which has been successfully operating all over Russia and the CIS member-states 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 warehouse in Moscow, with the total area of 180 square meters. Today, Synergy Research Group is represented in Moscow, Saint-Petersburg, Novosibirsk, Yekaterinburg and Almaty (Kazakhstan). The company’s headquarters are in Moscow.
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