With Russia taking up so many column inches in the Western press (not all wanted) it seems a strange time to be investing in clinical trials there. However, a perfect storm of factors including easing regulation and cheap running costs is making the clinical trials sector surge ahead.
Back in 2009, the Synergy group predicted that Russia could be a “potential superpower” in clinical trials. It still has a way to go but with a 13% increase in the number of trials in the third quarter of this year, it could be slowly getting there.
Russia’s centralised healthcare infrastructure makes patient recruitment relatively straightforward. Combine this with costs that are only 20-30% of the Western European & US equivalents, and the advantages are clear.
Russia also has a good level of adherence to Good Clinical Practice, which increases confidence that trials will be run ethically and effectively. Whitehall Training has even developed its own Russian language GCP course to meet the strong demand. It also has a Russian language version of its course covering Good Manufacturing Practice for clinical trial drugs – GMP (Annex 13). In addition to these, the company has two Russian courses about adverse drug reactions - Pharmacovigilance 1 - Drug Safety and Pharmacovigilance 2 - Global Regulations.
Until recently, laws were in place that required sponsors to have previously done pre-clinical trials and drawn up a registration dossier before a trial could start. They were also required to carry out bioequivalence studies regardless of the level of difficulty.
The easing of these clinical trial laws and a reduction in test drug import tariffs mean that Russia could well become the destination of choice for many future trials.
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