Clinical Trials in Russia: Q3 2010

On December 12, 2010, Synergy Research Group (SynRG), a Russia-based CRO, presented the English version of SynRG Orange Paper Q3 2010, the quarterly analytical report on 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 new law “On circulation of medicines” became effective on 1 September 2010. According to this law the right to issue the license for performing Clinical researches was transferred from The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (alias RosZdravNadzor, RZN) to the Ministry of Healthcare and Social Development. Due to this transmission the issue of licenses was temporary suspended in September. In our opinion it caused the decrease of the main indicators of clinical researches’ market comparing to the corresponding period of the last year.

RZN approved 134 new clinical trials of all types including local and bioequivalence studies during the third quarter of 2010 demonstrating a 12% decrease comparing to the last year figure.
The main contribution into the total number of studies is still made by multinational multi-center clinical trials, even though the number of these studies descended by one third over Q3 2009 and stood at 60 new studies in Q3 2010. The number of local clinical trials conducted in Russia by domestic and foreign sponsors demonstrated a 7% increase and stood at 42 trials.

Although most of clinical trials in Russia are still being sponsored by foreign companies (57%), the ratio between foreign and domestic companies changed significantly: in Q3 2009 their shares were 67% and 33% respectively, while in Q3 2010 the share of trials sponsored by domestic companies increased up to 43%.

Clinical trials initiated in Q3 2010 were sponsored by manufacturers from 17 countries. The maximum number of trials was initiated by Russian sponsors, American sponsors took the runner-up place, they are followed by German and Swiss sponsors, and the top six is concluded by French, Belgian and Belarusian sponsors each with four new studies.

Twelve new Phase I clinical trials were launched in the third quarter of 2010; three trials more than in the corresponding quarter of last year. The number of the Phase II trials decreased significantly from 47 trials in the third quarter of 2009 to 18 in the third quarter of 2010. The number of Phase III trials also demonstrated a decrease over last year number, down from 86 to 61 studies, while the number of Phase IV studies remained almost unchanged – 10 new trials.

The number of patients which are planned to be enrolled in the Phase II-IV trials launched in the third quarter of 2010 stood at 11,758 – a bit less than the last year number. The number of Phase III subjects increased by 24% from last year’s figure.

The Swiss giant Novartis sponsoring 7 new studies is on the top of the heap in the third quarter of 2010. The German Boehringer Ingelheim with five new trials in Q3 2010 took the runner-up place. It is followed by British Pantheon and GlaxoSmithKline each sponsoring five new studies. The top five is concluded by French sanofi-aventis having four new studies in Q3 2010.

The Russian pharmaceutical company ZAO Rafarma sponsoring five new clinical trials ranked number one among domestic pharmaceutical manufacturers by the number of new studies in the third quarter 2010. They are followed by NIOPIK and ZAO Pharm-sintez with three new trials each and ZAO Firn M with two new trials. ZAO Vector-Medica and OOO Niarmedik withone new study each and the same number of patients and sites conclude top six.
62% per cent of the new studies in Q3 2010 were conducted in the five leading therapeutic areas. The maximum number of trials (20) was initiated in Oncology; 13 clinical trials in Neurology; 10 new studies in Infectious Diseases; nine – in Respiratory diseases and eight new Endocrinology studies were initiated in Q3 2010.

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. Today, Synergy Research Group is represented in Moscow, Saint-Petersburg, Novosibirsk, Yekaterinburg, Perm, Rostov-on-Don, and also in Almaty and Astana in Kazakhstan. The company’s headquarters are in Moscow.