Moscow, Russia, February 20, 2008 --(PR.com
)-- On February 18, 2008 Synergy Research Group (SynRG), a Russia-based CRO, presented the current issue of its Orange Paper, a regular analytical report on the market of clinical trials in Russia. The report contains hundreds of figures as well as dozens of tables and pictures covering various aspects of the Russian Clinical Trials 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 – few of the key strategic objectives of SynRG.
During the Q4 2007 the RZN approved 174 new clinical trials in Russia showing a 23% increase over the Q4 2006. The main growth was contributed by international multi-center clinical trials, which increased by 54% and accounted to 131 studies in Q4 2007, - the maximum number during the whole history of clinical trials in Russia.
The share of international multi-center trials in Q4 2007 stood at 75%, and the shares of local and bioequivalence studies stood at 18% and 7%, respectively. The lions share of clinical trials in Russia is conducted by foreign sponsors, in Q4 2007 82% of the total number of studies were initiated by 71 manufacturers from 20 countries.
The total number of patients to be enrolled in clinical trials started in Q4 2007 is 23,745, which is 2.7 times more than in the corresponding quarter of the past year. The minimal number of subjects is four, and the maximum number of patients is 5,000. The shortest trial lasts two months, while the longest will take five years.
The French sanofi-aventis holds the first place among foreign sponsors in terms of number of trials initiated in Q4 2007. It is followed by American Merck & Co., British GlaxoSmithKline slips to the third place this quarter. Russian sponsors are led by pharmaceutical company LEKKO, it is followed by Microgen and Schelkovsky Vitamin Plant.
21 of 44 new drugs approved by Food and Drug Administration (FDA) and European Medicine Agency (EMEA) in Q4 2007 were, or are being tested in the clinical trials in Russia. Top six therapeutic areas of the clinical trials started in Russia in Q4 2007 are: oncology, cardiovascular, respiratory; nervous, gastro-intestinal and endocrine disorders.
According to the RZN data, as of 9 January 2008 there are 854 investigator sites in Russia, 27 of which were accredited by the RZN in Q4 2007.
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.