Russia approves 95 new clinical trials in first quarter
The Ministry of Health and Social Development of the Russian Federation (MoH) approved 95 new clinical trials of all types including local studies during the first quarter of 2011, 29% less than the year-ago quarter, according to a quarterly analytical report produced by Moscow-based CRO Synergy Research Group (SynRG).
The quarterly report on Russia’s clinical trial market is another step in improving the research attractiveness of Russia for foreign sponsors, one of SynRG’s goals.
Of the 95 new studies approved, 74 were multi-national, multi-center clinical trials, that number also down 11% from the first quarter of 2010. The number of local clinical trials conducted in Russia by domestic and foreign sponsors is also down from 36 to 18.
Clinical trials in Russia in the first quarter were sponsored by companies from 15 countries. The maximum number of trials—22—was initiated by U.S. sponsors; Russian sponsors had 19 studies; Swiss sponsors had 15 and U.K. companies had 10.
The number of subjects planned for enrollment in phase II-IV trials launched in the first quarter was 11,123 subjects, 15% less than a year ago.
GlaxoSmithKline is sponsoring eight new studies, while Novartis has six new trials, AstraZeneca and Roche each has five, and Sanofi has four.
Of the new studies, 74% were in five leading therapeutic areas: the maximum number of trials—29—was initiated in Oncology; 12 in Respiratory diseases; 11 in Endocrinology; seven in Cardiovascular diseases, and six in Musculoskeletal diseases.