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Clinical Trials in Russia. 3rd Quarter 2008

November 11, 2008

Orange Paper On November 11, 2008 Synergy Research Group (SynRG), a Russia-based CRO, presented the current issue of its Orange Paper, a regular analysis of the clinical trial market in Russia. The report contains hundreds of figures as well as dozens of tables and pictures covering various aspects of the Russian clinical trial market. This is another step to formation of a civilized market of clinical trials in Russia and improvement of the research attractiveness of Russia for foreign sponsors, one of the SynRG’s key strategic goals.

The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (alias RosZdravNadzor, RZN) approved 170 new clinical trials during Q3 2008, a 20% increase over the corresponding period of last year. The main contribution (58%) is made by multinational multi-center clinical trials, their number increased by 8% over Q3 2007 and stood at 98 new studies in Q3 2008.

Clinical trials in Russia in Q3 2008 were sponsored by manufacturers from 39 countries. The maximum number of trials (58) was initiated by Russian sponsors, American sponsors (38 trials) took the runner-up place, they are followed by the German (14) and Swiss (12) companies, and the top six is concluded by the UK sponsors  with 8 new trials.

Eight new Phase I clinical trials were launched in the third quarter of 2008; which is the same as in the corresponding quarter of last year. The number of the Phase II trials slightly decreased from 44 trials in the third quarter of 2007 to 39 in the third quarter of 2008. The number of Phase III trials demonstrated the biggest increase, 62% up over last year, from 58 to 94 studies. The number of Phase IV trials slightly increased from 9 in Q3 2007 to 13 in Q3 2008.

Twenty three thousand patients are planned to be enrolled in the Phase II-IV trials instigated in the third quarter of 2008, 63% up on last year number.
The worldwide pharmaceutical giant Pfizer sponsoring seven new studies was on the top of the pile in the third quarter of 2008. The French sanofi-aventis instigating five new trials in Q3 2008 took the runner-up place, it is followed by the Swiss Roche, and two Americans – Eisai and Merck & Co. with the same number of trials but fewer patients/sites.

The Russian Biocad, sponsoring seven new clinical trials ranked number one among domestic pharmaceutical manufacturers by the number of new studies in Q3 2008. The top five débutant company Firn M with four new trials took the runner-up place. It is followed by Valenta, NIOPIK and Russian Cardio Complex (RKNPK).
Almost three-fourth of the new studies in Q3 2008, or 73%, were instigated in the following six therapeutic areas: Oncology (26); Neurology (24); Cardiovascular (20); Blood diseases (19); Endocrine and metabolic diseases (13 ) and Infectious diseases (12).

Synergy Research Group (SynRG™) is a Russian contract research organization, which has been successfully operating in Russia since 2002. SynRG™ offers a broad range of services for conducting clinical trials for Russian and foreign pharmaceutical and biotechnological companies – from registration of the studies in regulatory authorities to pharmaco-economic surveys. The company has its own clinical depot in Moscow, with the total area of 180 square meters. Today, Synergy Research Group is represented in Moscow, Saint-Petersburg, Novosibirsk, Yekaterinburg, Perm and Almaty (Kazakhstan). The company’s headquarters are in Moscow.

Orange paper download page