New Russian trial approvals down 26% in Q2

The number of clinical trials approved by Russia’s Federal Surveillance Service for Healthcare and Social Development (Roszdravnadzor/RZN) continued to fall in the second quarter of 2009, dropping 25.9% from 174 trials in the same period of 2008 to 129 in the latest quarter.

New trial approvals in Russia had already declined by 13.1% year on year in the first quarter. As in that period, the volume of Phase II studies cleared by the RZN in the second quarter was down significantly, by 27.5% year on year to 29. The number of Phase III trials, at 64, was 22.9% below the second quarter of 2008, while Phase IV studies lagged 33.3% behind at 10.

The volume of Phase I trials dropped by 12.5% from a lower base, from eight to seven. The figures published by Moscow-based contract research organisation (CRO) Synergy Research Group also included 19 approved bioequivalence studies, compared with 26 in Q2 2008.

Multinational, multicentre clinical trials still accounted for the bulk of the new studies approved by the RZN in the latest quarter. While the number of multinational trials was down by 22.4% year on year to 83, the share of these studies in the regulator’s approval tally climbed from 61% to 64%. The volume of local clinical trials run in Russia by domestic or foreign sponsors fell by 34.1% to 27 in total.

International sponsors were responsible for 67% of the trials cleared in the second quarter, almost the same as in Q2 2008 (68%). On a country by country basis, Russia came out top, sponsoring 32% of the total, followed by the US (29%), Switzerland (10%) and Germany (9%).

Novartis was the leading international sponsor, backing 11 of the 129 new clinical trials cleared in Russia during the second quarter. Pfizer and Bristol-Myers Squibb were in second and third place, with eight and six trials respectively. The leading Russian sponsor was Valenta with five newly approved trials.