According to Russia-based contract research organization (CRO) Synergy Research Group’s Annual Orange Report, Russia’s regulatory agency Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (RosZdravNadzor, RZN) approved 577 new clinical trials during 2009, 6% fewer than in 2008. Sixty percent, or 348 of the new studies, were multinational multi-center trials, down 4% from 2008.
Clinical trials in Russia in 2009 were sponsored by pharmaceutical companies from 28 countries. Most of them, 191, were initiated by Russian sponsors. U.S. sponsors initiated 128 trials followed by 51 trials by German sponsors, 42 by Swiss sponsors, 35 by UK sponsors, and 34 by Japanese sponsors.
In 2009, 85% of the new studies initiated in Russia fell into six major therapeutic areas. The greatest number of studies were initiated in the field of oncology, at 104 clinical trials. Sixty-six studies each were initiated in endocrine and metabolic diseases, and in respiratory diseases; 64 were initiated in cardiovascular; 40 in musculoskeletal and 38 in central nervous system.
Seven FDA inspections were conducted at Russian investigative sites during 2009, according to FDA data.
The full report will be presented by Synergy Research Group at the DIA EuroMeeting in Monaco during March 8-10, 2010, and will be available at Booth #5.