Clinical Trials in Russia: Year 2009

Synergy Research Group (SynRG), a Russia-based CRO, presented the Russian version of SynRG Orange Paper 2009, the annual 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 577 new clinical trials during 2009, a 6% less than in 2008. The main contribution (60%) is made by multinational multi-center clinical trials, though their number decreased by 4% over 2008 and stood at 348 new studies in 2009.

Clinical trials in Russia in 2009 were sponsored by the pharmaceutical manufacturers from 28 countries. The maximum number of trials (191) was initiated by Russian sponsors as before. American sponsors (128 trials) took the runner-up place, they are followed by the German (51), the Swiss (42), the UK (35) companies, and the top five is concluded by the Japanese sponsors with 34 new trials.

The Swiss pharmaceutical giant Novartis sponsoring 35 new studies was on the top of the pile by the number of new trials started in 2009. The American Pfizer instigating 22 new trials in 2009 took the runner-up place, it is followed by Merck and GlaxoSmithKline with 20 new trials each, and Boehringer Ingelheim closed the top five with 16 new trials.

In 2009, 85% of new studies were initiated in six major therapeutic areas: greatest number of studies has been initiated in the field of Oncology – 104 clinical trials; Endocrine and metabolic diseases - 66; Respiratory System – 66; Circulatory System – 64; Musculoskeletal System – 40 and diseases of the Nervous System – 38 new clinical trials.

Seven FDA inspections were conducted in the Russian investigative sites during 2009, according to FDA data.

The full report will be presented at the DIA EuroMeeting in Monaco during 8-10 March 2010, and will be available at the booth No. 5.