SynRG Orange Paper: Clinical Trials in Russia 1st Quarter 2010

Synergy Research Group (SynRG), a Russia-based CRO, presented the English version of SynRG Orange Paper Q1 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 Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (alias RosZdravNadzor, RZN) approved 134 new clinical trials of all types including local and bioequivalence studies during the first quarter of 2010 demonstrating an 18% increase over the corresponding period of last year.

The main contribution into the total number of studies is made by multinational multi-center clinical trials, the number of them also increased by 15% over Q1 2009 and stood at 83 new studies in Q1 2010.

The number of the local clinical trials conducted in Russia by domestic and foreign sponsors is also up from 27 to 36 clinical trials demonstrating a notable 33% increase over the same point in 2009.

Clinical trials in Russia in Q1 2010 were sponsored by companies from 20 countries. The maximum number of trials (44) were initiated by Russian sponsors, American sponsors with 30 studies took the runner-up place, they are followed by German sponsors with 10 trials, eight new studies were instigated by the UK and Swiss manufacturers, and the top six is concluded by French sponsors with seven new studies in Q1 2010.

Eleven new Phase I clinical trials were launched in the first quarter of 2010; seven trials up over the corresponding quarter of last year. The number of the Phase II trials increased by 27%, from 26 trials in the first quarter of 2009 to 33 studies in the first quarter of 2010. The number of Phase III trials demonstrated a 7% increase over last year number, up from 59 to 63 studies.

The number of patients which are planned to be enrolled in the Phase II-IV trials launched in the first quarter of 2010 stood at 13,016 patients, demonstrating a 25% increase over the last year number.

The Swiss Novartis sponsoring seven new studies is on the top of the heap in the first quarter of 2010. GlaxoSmithKline with six new trials in Q1 2010 took the runner-up place. It is followed by Pfizer also sponsoring six new studies, but with less number of patients, and French Servier with four new studies. The top five is concluded by Merck & Co. having three new studies in Q1 2010.

The Russian pharmaceutical company OAO Sti-Med-Sorb sponsoring four new clinical trials enrolling 290 patients in five sites, ranked number one among domestic pharmaceutical manufacturers by the number of new studies in the first quarter 2010. OOO Geropharm with three new trials and 480 subjects in 11 sites took the runner-up place. It is followed by ZAO Infamed, ZAO Biocad and AKO Sintez with two studies each differing only in the number of patients and sites.

Sixty nine per cent of the new studies in Q1 2010 were conducted in the six leading therapeutic areas. The maximum number of trials (28) were initiated in Oncology; 12 clinical trials in Respiratory diseases; nine new studies in Psychiatry; seven new studies in Cardiovascular, Infectious and Musculoskeletal diseases were initiated in Q1 2010.