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The current state of the clinical trial market in Russia.
Russia remains an attractive country in which to base clinical trials, and the sector does not appear to be suffering markedly from the global economic downturn, according to a comprehensive market report published in early June by Synergy Research Group (SynRG), a Russian-based CRO.
Russia Recent Contributions to R&D
The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (RosZdravNadzor, RZN) approved 113 new clinical trials during first quarter (Q1) 2009, representing a 13% decrease against the same period in 2008.
Clinical trials in Russia in Q1 2009 were sponsored by companies from 28 countries. A total of 31 trials were initiated by Russian sponsors, and 20 studies were begun by companies from the United States, followed by Germany (12), Switzerland, Japan (8), and the UK (7). Boehringer Ingelheim and Novartis each sponsored seven new studies in Q1 2009, followed by Pfizer with six, Merck & Co. with four, and Hexal Biotech with three.
"The lion's share of clinical trials in Russia is still being sponsored by foreign companies," wrote the authors of the report, called the Orange Paper. "Whilst their share increased from 68% to 73%, their number is up from 82 in Q1 2008 to 88 new studies in Q1 2009. The number of trials initiated by Russian sponsors, including bioequivalence studies, rose from 31 to 42, but their share decreased from 32% to 27%."
Around 70% of new studies were initiated in six therapeutic areas: cardiovascular (17), neurology and oncology (16), infectious diseases (14), respiratory diseases (12), and endocrinology (11). The number of bioequivalence studies unveiled in the first quarter of 2009 was 14, compared with 13 over the same period in 2008.
"It looks like the economic crisis has not yet affected the clinical trial industry. The reason is twofold: the development cycle of a new drug is much longer than any crisis, and the elasticity of a medicine is low enough to stand the chaotic fluctuations of the world stock market," the authors wrote.
During Q1 2009, FDA's CDER approved 121 new drugs, of which five were tested in Russia. Over the same period, EMEA reviewed 161 applications to market drugs in the EU, and seven drugs were tested in Russia (see Table).
According to Alexandra Zaichenko, business development director of the OCT Group in St. Petersburg: "My general advice to sponsors is to avoid the prejudice that the infrastructure in Russia is as it was 20 years ago. Each site...is accredited by the Ministry of Health for GCP...and can't be approved without a certain qualification of the PI and other team members.—Philip Ward