A just-published analysis of the Russian clinical sector from local contract research organisation Synergy Research Group (SynRG) has painted a picture of a market with a high proportion of late-stage trials in chronic indications such as cancer and cardiovascular disease, with foreign companies still the driving force.
The number of Phase II trials actually declined over the prior year, but this was offset by a small increase in the number of Phase I trials – up by six to 38 – and a hefty rise in Phase III studies which rose 20 per cent to 282.
Cancer and cardiovascular disease made up the largest proportion of studies with 14 per cent of the total apiece, followed by respiratory indications with around 10 per cent.
Local sites and FDA inspections
According to the data from Russia’s Federal Service on Surveillance in Healthcare and Social Development (RZN), as of the 12 November 2008 there were 946 hospitals licensed to conduct clinical trials in Russia. 92 new sites were approved by the RZN during the course of the year.
Roughly a third of trials were sponsored by Russian groups, with US sponsors accounting for around a quarter of the total, with German, UK and Swiss sponsors rounding out the top 5, all with under 10 per cent.
“The lion’s share of clinical trials in Russia is still being sponsored by foreign companies,” said SynRG. ”Whilst their share slightly decreased from 72 per cent to 67 per cent, their number is up from 407 in 2007 to 414 new studies in 2008, since the number of local studies grew faster during the period.”
Novartis topped the table of multinational sponsors with 22 studies, shadowed by Sanofi-Aventis with 21 and GlaxoSmithKline with 20. Pfizer and Merck & Co make up the top 5 with 18 apiece.
Among domestic sponsors, ZAO Valenta Pharmaceutica backed 14 new trials, with more than 1,000 patients enrolled, followed by ZAO Biocadwith 11 trials involving 630 patients. The runners up were OAO Sintez and OAO Nizhpharm with nine trials apiece, followed by FGUP NIOPIK with eight.
According to data from the US Food and Drug Administration (FDA), as of 7 January 2009, 13 FDA inspections had been conducted at Russian investigative sites during 2008, - the maximum annual number since 1995 when the first FDA inspection was conducted in Russia.
No objectionable conditions or practices were found during seven of the inspections, and while some issues were uncovered during the other six these did not require any regulatory action.