The number of new studies approved in Russia during the third quarter of 2011 reached last year’s level, with the Ministry of Health and Social Development of the Russian Federation (MoH) approving 132 new clinical trials of all types, including local and bioequivalence studies, according to Synergy Research Group (SynRG), a Russia-based CRO. That’s only two trials below the number approved in the year-ago quarter.
Multinational, multi-center clinical trials increased 40% to 84 new studies in the third quarter. The share of multinational, multi-center clinical trials stood at 64% of total clinical trials in the quarter, while local and bioequivalence studies were 25% and 11%, respectively.
These numbers are featured in Synergy Research Group’s (SynRG) Orange Paper, a quarterly analytical report on the clinical trial market in Russia. SynRG said the report, which contains data covering various aspects of the Russian clinical trial market, is another step in establishing a transparent clinical trial market in Russia and improving the research attractiveness of Russia for foreign sponsors.
Clinical trials in Russia in the third quarter were sponsored by companies from 17 countries. The maximum number of trials (44) was initiated by Russian sponsors. American sponsors had 40 new studies, followed by Swiss sponsors with 19 trials, Danish sponsors with six new studies and French sponsors with four new studies.
During the quarter, 17 new phase I clinical trials were launched, five more than in the year-ago quarter. The number of phase II trials stood at 19 new studies, while the number of phase III trials increased almost 23%, from 61 to 75 studies, from a year ago. Phase IV trials jumped from 10 to 21 studies.
The number of patients planning to be enrolled in phase I-IV trials launched in the quarter stood at 13,211, 12% more than a year ago.
Merck is sponsoring seven new studies, followed by Roche, Novartis and Novo Nordisk, each having five new trials. Pfizer has four new studies. Russian Biocad, sponsoring six new clinical trials, topped domestic pharmaceutical manufacturers in the number of new studies in the quarter. Russian Obolenskoe also has six new trials, but fewer patients, followed by Canonpharma with four new studies, Valenta with three and Pharmstandart with two new trials.
More than 75% of new studies in the third quarter were initiated in seven leading therapeutic areas: Oncology (27); Pulmonology (14); Hematology (13); Cardiology (11); Musculosceletal diseases (9); Infectious diseases (8) and Neurology (7).
The Center for Drug Evaluation and Research (CDER) of the FDA approved 18 new drugs during the quarter, of which nine were studied in clinical trials conducted in Russia. The Committee for Medicinal Products for Human Use (CHMP) of the EMA approved 23 new drug applications, 14 of which were tested in Russian sites.
SynRG is a Russian CRO operating in Russia since 2002. Its headquarters are in Moscow.