The comment follows the publication of the English language version of Synergy’s ‘Orange Paper,’ which showed that 95 trials were initiated in the first quarter, down 29 per cent on the number started during the equivalent period in 2010.
Synergy, a Moscow-based contract research organisation (CRO), attributed much of the decline the fact that fewer multinational, multi-center research programmes had included a Russian site during the period compared with Q1 last year.
Additionally, the number of studies conducted solely in Russia was also down, falling 50 per cent to 18. There were seven fewer Phase I trial, 11 less Phase II and 10 per cent less Phase III programmes.
Regulatory revisions
However, the decline is not indicative of a lack of demand according to Stefanov, who told Outsoutcing-pharma.com that: “I would regard this reduction as a temporary blip, rather than a trend.
Instead he linked the drop to changes to Russia’s laws, which saw responsibility for approval trials change from one regulatory authority, the Roszrdarnadzor, to the Ministry of Health and Social Development (MoH)
“Such a transfer is quite a painful process, and it seriously affected the approval process…the number of studies approved in September-October last year was zero.
“The demand for [clinical research in] Russia is still high, and once the approval process is back on track, we'll be definitely enjoying the long term trend of growth in the number of trials that we saw in 2000-2009.
Stefanov also suggested that recent changes to Russia's “Circulation of Medicines" laws, which made conducting trials in the country a mandatory requirement for product approval, would aid recovery.
This contention echoes the conclusions of recent analysis by GBI Research, which cited the new law as one of the factors that would drive the value of the Russian trial sector to around $309m by 2017.