Clinical Trials in Russia. 1st Quarter 2008
On June 2, 2008 Synergy Research Group (SynRG), a Russia-based CRO, presented the current issue of its Orange Paper, a regular analytical report on the market of clinical trials in Russia. According to the report The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (alias RosZdravNadzor, RZN) approved 130 new clinical trials in Russia in Q1 2008.
The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (alias RosZdravNadzor, RZN) approved 130 new clinical trials in Russia in Q1 2008; four trials less than in the corresponding period of last year. The main contribution is still made by multinational multi-center clinical trials. Their share in the total volume has not changed in comparison with the last year, amounting to 62 per cent, and their number has slightly declined from 83 to 80 clinical trials.
The share of foreign study sponsors In Q1 2008 stood at 68 per cent of the total number of clinical trials, 88 new trials were initiated during this period. Domestic sponsors have launched 42 clinical studies during Q1 2008 and their share accounted to 32 per cent of the total number of trials.
Forty companies from 18 countries have sponsored new trials during Q1 2008. Russia with 42 clinical trials is on the top of the heap, followed by the USA with 33 trials, UK (15 clinical trials), Switzerland (11 clinical trials) and Germany (10 clinical trials).
The number of patients to be enrolled in all types of studies stands at 9,358; a 60% decrease over Q1 2007, when 14,894 patients were planned to be recruited.
The British GlaxoSmithKline remains at the Q1 top for a second consecutive year starting 12 new trials and having considerable advantage. Its major rival, the American Pfizer with six trials has moved up from the fourth position in Q1 2007 to the second position in Q1 2008. The Swiss Novartis also running six trials but with less number of patients is number 3 in the list. The Russian Pharmstandard with four new studies was ranked number one among domestic sponsors.
In Q1 2008 more than half of the new trials (53 per cent) were launched in six leading therapeutic areas. The maximum number of trials (18 clinical trials) traditionally are in oncological diseases; 13 clinical trials were devoted to treating diseases of respiratory system; 11 neurologic and 11 endocrinological trials were started; 10 cardiovascular system trials; seven trials of gastrointestinal disturbance.
Synergy Research Group (SynRG™) is a Russian contract research organization, which has been successfully operating all over Russia and the CIS member-states 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 warehouse in Moscow, with the total area of 180 square meters. Today, Synergy Research Group is represented in Moscow, Saint-Petersburg, Novosibirsk, Yekaterinburg and Almaty (Kazakhstan). The company’s headquarters are in Moscow.
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