A total of 114 new clinical trials were approved by Russia’s Ministry of Health during the second quarter of 2011, 36% fewer than in the same quarter last year.

Bucking that trend, though, were multinational, multicentre trials, which were up by 18% year on year to 91, according to Synergy Research Group (SynRG), the contract research organisation based in Russia that publishes quarterly reviews of clinical trial trends in its home market.

Multinational studies took an 80% share of all clinical trials approved in Russia during the second quarter. Locally-sponsored trials accounted for 12% of the total and bioequivalence studies for 8%, SynRG reported.

Sponsors from 20 countries in all had clinical trials approved in Russia during Q2. Companies from America accounted for the most studies (39), followed by sponsors from Russia (14), the UK and Switzerland (13 trials each) and Austria (five).

There were year-on-year declines in all phases of clinical trials cleared by the Russian Ministry of Health during the second quarter, other than Phase IV post-marketing studies. These latter were static at 14 trials approved, the same number as in Q2 2010.

A total of three Phase I studies were approved during the latest quarter, 10 fewer than in Q2 2010. The volume of Phase II trials fell by 20% to 23 and Phase III trial approvals were down from 83 to 64 (-23%).

GSK busy


GlaxoSmithKline was the leading sponsor of new clinical trials approved in Russia during Q2 2011, with seven studies cleared, followed by Roche, Eli Lilly and Boehringer Ingelheim (five trials apiece) and Merck & Co.

Materia Medica was the number one sponsor among domestic pharmaceutical companies, with two new trials approved. The Russian Centre of Cardiology had the same number of trials approved but with fewer patients, SynRG noted.

More than half of the new studies cleared in the latest quarter fell into seven leading therapeutic areas, with oncology accounting for the largest number (21), cardiology and infectious diseases for eight, rheumatology for seven, endocrinology and pulmonology for five, and psychiatry for four.