Clinical Trials in Russia. Year 2010..
The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor) and the Ministry of Health and Social Development of the Russian Federation (MoH) approved 492 new clinical trials of all types including local and bioequivalence studies during 2010, demonstrating a 15% decrease from the last year figure.
The number of the local clinical trials conducted in Russia by domestic and foreign sponsors increased from 144 to 161 clinical trials demonstrating a 12% increase over last year number. The number of multinational multi-center clinical trials decreased by 29% over 2009 and stood at 247 new studies in 2010.
The share of the local trials increased from 25% in 2009 to 33% of the total number of studies in 2010, and the share of bioequivalence studies also slightly increased from 15% to 17% of the total number of trials approved during Year 2010. The share of multinational multi-center clinical trials decreased from 60% to 50% of the total number of clinical trials approved in 2010.
Clinical trials in Russia in 2010 were sponsored by the companies from 31 countries. The maximum number of trials (210) were initiated by the Russian sponsors. American sponsors with 79 new studies took the runner-up place, they are followed by German sponsors with 41 trials, 33 new trials were instigated by Swiss companies, 23 trials were instigated by the UK sponsors and the group of leaders is concluded by French sponsors with 17 new studies in 2010.
The share of Phase III trials in 2010 stood at 58% of the total number of studies, the share of Phase II trials accounted at 22%, Phase IV trials stood at 9%, and the share of Phase I studies amounted to 11%.
The number of patients which are planned to be enrolled in the Phase II-IV trials launched in 2010 stood at 45,072, a 7% decrease from 2009 figure, when 48,521 patients were planned to be enrolled.
The Swiss pharmaceutical giant Novartis sponsoring 27 new studies is on the top of the heap in 2010. GlaxoSmithKline with 19 new trials in 2010 took the runner-up place; it is followed by Patheon, Boehringer Ingelheim and Merck & Co. each having nine new trials and differentiating only in the number of patients and sites.
The Russian company ZAO “Rapharma” sponsoring 10 new clinical trials, ranked number one among Russian sponsors by the number of new studies in 2010. It is followed by OAO “STI-MED-SORB,”, ZAO “Biocad” and FGUP “NIOPIK” each having five new trials and number of patients and sites. The top five is concluded by OOO “NPF Materia Medica” having four new trials in 2010.
In 2010, 63% of new studies were initiated in nine therapeutic areas: the largest number of studies has been initiated in Oncology (81); Endocrine and metabolic diseases and Respiratory System (37); Circulatory System (29); Infectious and parasitic diseases (28); Nervous System (27); Mental and behavioural disorders (25); Diseases of the musculoskeletal system (24) and 22 new clinical trials were dedicated to the Diseases of the genitourinary system.
Pavlov State Medical University of St. Petersburg with 79 new studies ranked the number one in the number of trials in 2010; it is followed by the Russian Oncology Scientific Center n/a N.N.Blokhin (47 studies); I.M. Sechenov First Moscow State Medical University (46 studies); the Russian State Medical University (39 studies) and the top five is concluded by the Kirov Military Medical Academy with 37 new trials in 2010.
Twenty three inspections were conducted by Roszdravnadzor in Russia during 2010, 15 violations of the clinical practice were found, seven of them were qualified as critical. Six FDA inspections were conducted in the Russian investigative sites during 2010, all ended with NAI result - no actions indicated.
Synergy Research Group (SynRG[TM]) is a Russian contract research organization, which has been successfully operating in Russia since 2002. SynRG[TM] 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, Krasnodar, Rostov-on-Don, and also in Almaty and Astana (Kazakhstan) and Kyiv (Ukraine). The company's headquarters are in Moscow.
Synergy Research Group
+7 495 600 4445
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|Publication:||PR.com (Press Releases)|
|Date:||Jun 27, 2011|
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