Moscow, Russia, October 25, 2015 --(PR.com
)-- Synergy Research Group, a Russia-based CRO, presented the new issue of Synergy’s Orange Paper, the analytical report on the clinical trial market in Russia in the third quarter of Year 2015. The report contains data covering various aspects of the Russian clinical trial market. This is another step in establishing a transparent clinical trial market in Russia and improving the research attractiveness of Russia for foreign sponsors.
The Ministry of Health of the Russian Federation approved 203 new clinical trials of all types, including local and bioequivalence studies, during the 3rd Quarter of 2015. This represents a 13% increase over the same period of last year.
The main contribution into the total number of studies was made by multinational multi-center clinical trials (MMCT), the number of these studies is 86 and it is 19% more than in Q3 2014. The number of bioequivalence studies (BE) increased from 67 studies in Q3 2014 to 77 in Q3 2015, a 15% increase from last year’s figure. The number of local clinical trials (LCT) slightly decreased from 41 in Q3 2014 to 40 in Q3 2015.
The share of multinational multi-center clinical trials was 42% of the total number of clinical trials in Q3 2015, while bioequivalence and local studies amounted to 38% and 20% respectively.
Clinical trials in Russia in Q3 2015 were sponsored by companies from 28 countries. The maximum number of trials (81) was initiated by Russian sponsors. American sponsors with 31 new studies took the runner-up place; they are followed by Swiss sponsors with 24 trials, Indian sponsors with ten studies, then Belgian and Slovenian sponsors each with six studies. The group of leaders is concluded by UK and French sponsors each having five new studies.
The number of Phase I clinical trials slightly decreased from 13 in Q3 2014 to 12 in Q3 2015. The number of Phase II studies increased from 15 in Q3 2014 to 21 new studies in Q3 2015. The number of Phase III trials increased from 79 to 90 studies, 14% more than in Q3 2014. Phase IV trials showed a decrease from six studies in Q3 2014 to three studies in Q3 2015.
The number of subjects planned to be enrolled in Phase I-IV trials launched in Q3 2015 is 10,689, 16% less than the Q3 2014 figure, when 12,705 subjects were planned to be enrolled.
Roche is on the top of the heap in Q3 2015 by sponsoring nine new studies. It is followed by Novartis sponsoring seven new studies, then Janssen and Bristol-Myers Squibb each having six new trials and differing in the number of patients. The top five are concluded by Novo Nordisk having three new trials in Q3 2015.
The top five domestic pharmaceutical manufacturers by the number of new studies in Q3 2015 is headed by Valenta and Pharmasyntez, each having three new trials and differing in the number of patients. They are followed by Akrikhin, Pharmaceutical factory SPb and OAO Pharmsyntez, each having two new trials and differentiating in the number of patients.
The top five Russian study sites by the number of new clinical trials are: Pavlov First St.Petersburg State Medical University (24 studies); Russian Scientific Oncology Center n/a N.N. Blokhin (22 studies); St.Petersburg City Oncology Clinic (15 studies); Kazan State Medical University (14 studies) and Clinical Hospital No.2, Yaroslavl (13 studies).
83% of new studies in Q3 2015 were initiated in eight leading therapeutic areas: the largest number of studies was initiated in Oncology (28); 25 new studies were instigated in Pulmonology. Ten new studies were initiated in Infectious and parasitic diseases, as well as in Musculoskeletal diseases and Neurology. Nine new studies were started in Gastroenterology, eight new studies – in Endocrinology, and five studies – in Urology.
The Center for Drug Evaluation and Research (CDER) of the FDA approved 30 new drugs during Q3 2015, and 12 of them were (or are being) studied in clinical trials conducted in Russia.
During the third quarter of 2015, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMEA) gave positive recommendations on 29 new drug applications. 18 of the drugs which received positive opinions were (or are being) tested in clinical trials in Russia.
Synergy Research Group, http://www.synergycro.ru , is a full-service Contract Research Organization (CRO) founded in 2002 that delivers its Troika Promise of Speed, Cost and Quality to clients. Synergy provides a full range of CRO services to help global pharmaceutical and biotechnology companies conduct successful and cost-effective clinical trials. The company provides transparency, access and control to sponsors during the entire project through its cloud-based monitoring system. Synergy has locations in Moscow, Saint-Petersburg, Novosibirsk, Yekaterinburg, Perm, Krasnodar, Almaty and Astana (Kazakhstan) and Kyiv (Ukraine). The company's headquarters are in Moscow.