Clinical Trials In Russia

The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor) and the Ministry of Health and Social Development of the Russian Federation (MoH) approved 492 new clinical trials of all types including local and bioequivalence studies during 2010, demonstrating a 15% decrease from the last year figure.

The number of the local clinical trials conducted in Russia by domestic and foreign sponsors increased from 144 to 161 clinical trials demonstrating a 12% increase over last year number. The number of multinational multi-center clinical trials decreased by 29% over 2009 and stood at 247 new studies in 2010.

The share of the local trials increased from 25% in 2009 to 33% of the total number of studies in 2010, and the share of bioequivalence studies also slightly increased from 15% to 17% of the total number of trials approved during Year 2010. The share of multinational multi-center clinical trials decreased from 60% to 50% of the total number of clinical trials approved in 2010.

Clinical trials in Russia in 2010 were sponsored by the companies from 31 countries. The maximum number of trials (210) was initiated by the Russian sponsors. American sponsors with 79 new studies took the runner-up place, they are followed by German sponsors with 41 trials, 33 new trials were instigated by Swiss companies, 23 trials were instigated by the UK sponsors and the group of leaders is concluded by French sponsors with 17 new studies in 2010.

The share of Phase III trials in 2010 stood at 58% of the total number of studies, the share of Phase II trials accounted at 22%, Phase IV trials stood at 9%, and the share of Phase I studies amounted to 11%.

The number of patients which are planned to be enrolled in the Phase II-IV trials launched in 2010 stood at 45,072, a 7% decrease from 2009 figure, when 48,521 patients were planned to be enrolled.