Russia’s Federal Service for Healthcare and Social Development (Roszdravnadzor/RZN) approved 174 new clinical trials during the second quarter of 2008, a 53% increase over the same period of 2007 and a return to the vigorous market growth seen in the second half of last year.
In the first quarter of 2008 the number of clinical trial starts had dipped slightly year on year, from 134 to 130. This was also a long way behind the 174 studies cleared by the RZN in the fourth quarter of 2007, as the Russian market shook off the effects of a temporary ban on exports of biological samples imposed by the Russian Federal Customs Service in late May 2007.
Outsourcing was a key factor in the Q2 growth surge, noted Moscow-based contract research organisation (CRO) Synergy Research Group. The number of multinational, multicentre trials approved by the RZN jumped 67% year on year to 107.
On an individual country basis, Russia still led the pack, sponsoring 58 studies during the second quarter of 2008, Synergy reported. American sponsors were behind 37 of the trials approved during Q2, followed by Germany (23), the UK (16) and France (10).
The leading company in this respect was Sanofi-Aventis, which sponsored 12 of the new trial starts in Russia, with Boehringer Ingelheim and Merck & Co accounting for eight studies apiece.
Most of the action came in Phase III, where the number of trial approvals more than doubled from 40 to 83 in the second quarter, while the volume of study participants rose by 63%. Phase II trials also showed a substantial year-on-year increase, from 25 to 40.
In all, Synergy Research said, 12,000 patients are scheduled to enrol in Phase II-IV trials launched in Russia during Q2 2008, 24% more than in the year-before period.
