According to an Orange Paper released by Russia-based CRO, Synergy Research Group, Russia’s health agency, the Federal Service on Surveillance in Healthcare and Social Development (RosZdraNadzor, RZN) approved only 129 new clinical trials, including local and bioequivalence studies, during Q2 2009, representing a 17% decrease from Q2 last year. The percentage of approved multinational clinical trials increased slightly, however, to 65% of the total during this time period.
For phase II to IV clinical trials launched in Q2, 12,338 patients were enrolled—nearly the same as the 12,000 enrolled in the same quarter last year.
Clinical trials conducted in Russia were conducted by sponsor companies from 16 countries, with the most being initiated by Russian companies, followed by companies based in the U.S., Switzerland, Germany, UK and Japan and others.
Seventy-five percent of the studies in Q2 2009 were conducted in the following six therapeutic areas: cardiovascular, oncology, endocrinology, respiratory, infectious diseases and neurology.