Industry trials in BRIC countries - Russia, Moscow and St. Petersburg stand out

Abstract

The four so-called ‘BRIC’ countries - Brazil (191 million), Russia (142 million), India (1,136 million) and China (1,331 million) – together account for 59.7% of the world population. Yet they account for only 5.9% of industry sponsored clinical trial sites globally – and only 22.2% of among emerging countries. However, a recent 4.3% drift has been noted from North America and Europe to emerging countries, with about a third of those 6,500 sites located to BRIC. This study compares industry sponsored clinical trial activities among the four countries. Russia has more phase II-IV trials (n=620) than any of the other three BRIC countries. Brazil and India both account for about 75% of Russia’s total. China has fewer than 50% (n=268). The proportion of locally conducted trials – i.e. those conducted in one single country – is highest for China (49.3%), followed by Brazil (17.6%), India (9.3%) and Russia (5.3%). The number of active sites for multi-national industry sponsored trials is highest for Russia (n=3,364), followed by India (n=2,149), Brazil (n=1,988) and China (1,044). The number of sites per active multi-national trial is highest for China (9.4 sites per trial), followed by Russia (8.4), India (7.3 and Brazil (6.9). The vast majority of multi-national trials are phase III – about 85% for China and 75% for the other three BRIC countries. Oncology (27.2%) and cardiovascular (24.4%) account for more than 50% of multi-national trials in the four BRIC countries. Some sponsors are highly active in those countries, with over 700 active sites in total. Others are less active, with fewer than 400 active sites. Sites in Russia and China are both mostly located (56-57%) in two major cities – namely Moscow (31.2%) and St. Petersburg (24.9%) in Russia, and Beijing (34.3%) and Shanghai (22.4%) in China. On the other hand, India has a more diversified geographic distribution of sites, with only 20.5% in the two most active cites of Bangalore and Mumbai. Clearly, the four BRIC countries hold enormous potential to become major players in international clinical research. A continuing drift of study sites from North America and Europe to emerging countries is anticipated, especially to the BRIC countries. A clear exception is China, due to its strict and conservative regulatory framework and shortage of experienced, accredited investigators/sites undermining its opportunity to significantly expand in the international clinical research playing field.