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Russia initiates most clinical trials in Q1

Russia has witnessed a drop in generating new business activity on the clinical trials scene over the past year, but has been increasing its own activity in this field.

According to data produced by Russian contract research organisation (CRO) Synergy Research Group, the country was on the top of the heap in initiating new clinical trials in the beginning of the year.

Forty companies from 18 countries sponsored new trials during the first quarter of 2008, with 42 originating from Russia, 33 in the US, 15 in the UK, 11 in Switzerland and 10 in Germany.

More than half of the new trials (53 per cent) initiated by Russia were in six leading therapeutic areas - oncology, respiratory, central nervous system (CNS), endocrinology, cardiovascular and gastrointestinal.

Despite Russia leading the pack in instigating new trials, figures from Synergy actually showed that the country's clincial trials industry has itself had a slight decline in new business since the first quarter of 2007.

The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (RosZdravNadzor) approved 130 new clinical trials in Russia in the first quarter of 2008; four less than in the corresponding period of last year.

The size of the trials being run is also notably smaller, with the number of patients planned for enrollment in all types of studies standing at 9,358; a 60 per cent decrease over the first quarter of 2007, when 14,894 patients were planned for recruitment.

However, these figures may have been impacted by a temporary biologics ban imposed by the country's government last year, that without warning prevented the export from the country of all human medical biological materials, including blood and human tissue.

The biologics ban impacted clinical trials being run in the country and may have resulted in some sponsors deciding to take their business elsewhere in the future.

Meanwhile, despite the evident progress of Russia in initiating its own research programmes, the main contribution to the countrys clinical trials industry is still being made by multinational multi-center clinical trials - accounting for 62 per cent of all trials being run. Incidentally, during the past year their number has also slightly declined from 83 to 80.

UK drug giant GlaxoSmithKline remains the biggest donor of business for the second year in a row, with the firm starting 12 new trials in the first quarter.

Meanwhile rival firm has Pfizer stepped up its activity in Russia, initiating six trials during the period and moving up to second place in terms of new clinical business awards, up from the fourth position in the first quarter of 2007.

In total, 88 new trials were instigated by foreign sponsors during the quarter. Swiss firm Novartis sits in third place, also running six trials but with less number of patients.

Of the domestic trial sponsors, who launched 42 studies in Russia during the period, Pharmstandard was the dominant player, starting four trials.

According to the the US National Institute of Health NIH, 4,470 new clinical trials were launched worldwide during the first quarter of the year, with 2, 422 trials (54 per cent) in the USA and 996 (22 per cent) in Europe.

Russia's 130 trials pales in comparison to these figures, but with its vast population and lucrative market potential, the countrys clinical trials industry is increasingly attracting the interest of global players. This has been highlighted in particular by two recent business transactions.

At the beginning of this year, two Russian CROs were acquired by big multinational CROs - in February US-based PPD bought Smolensk-based Innopharm, and in April i3 announced the purchase of Moscow-based Lege Artis.

Acquiring an already-established firm is one of the quick ways for an international CROs to enter the Russian clinical trial market, said Synergy.

The advantage of taking this approach is that the company immediately gets a solid local presence, although Synergy said the downside can be that this also exposed them to an increased risk of encountering some difficulties down the line with the integration of cross-cultural corporate differences, processes, and technologies.


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