| Igor Stefanov at Synergy Research Group analyses the facts and figures surrounding clinical trials in Russia in 2007
Russia’s clinical trials market has been enjoying significant growth since the early 1990s when the first trials were introduced. This growth has been especially notable since 1997, in which time the number of studies conducted in Russia has nearly tripled. It is also of interest that the share of international multi-centre studies has substantially increased during the last decade – from 35 per cent in 1997 to 66 per cent in 2007 – a very good indicator for an emerging clinical research market.
The data obtained from Russian investigator sites is now fully accepted by the US FDA and the European Agency for the Evaluation of Medicinal Products (EMEA). Indeed, six out of nineteen drugs approved by the FDA in 2007 had been developed with data coming collected during Russian studies (1). The high quality of Russian investigator sites is also confirmed by 36 FDA inspections conducted in Russia since 1995, with no major findings in 35 cases – the lowest deficiency rate among emerging markets (2).
Another factor behind the recent growth is that pharmaceutical manufacturers have begun to regard Russia as a potential new market for their drugs. According to the data provided by DSM Group, the total sales volume of the Russian pharmaceutical market in 2006 amounted to US $12.3 billion (3).
All of these factors – along with Russia’s traditionally high patient recruitment rate, transparent regulatory system and stable political climate – make the Russia of today one of the most attractive clinical research markets in the world. The figures themselves aim to provide an accurate snapshot of the clinical trials market in Russia at the end of 2007. |
