700 new studies approved in Russia during 2017

The Ministry of Health of the Russian Federation approved 700 new clinical trials of all types, including local and bioequivalence studies, during 2017. This represents a 22% decrease over 2016.

The main contribution into the total number of studies in 2017 was made by multinational multi-center clinical trials (MMCT), the number of these studies is 291 and it is 9% less than in 2016. The number of bioequivalence studies (BE) decreased from 302 studies in 2016 to 215 in 2017, a 29% decrease from last year’s figure. The number of local clinical trials (LCT) significantly decreased from 276 in 2016 to 194 in 2017.

Breakdown by Study Phase

The number of Phase I clinical trials has decreased from 83 studies in 2016 to 46 new studies (45% decrease). The number of Phase II trials has increased from 92 studies in 2016 to 93 new studies (1% increase). The number of Phase III trials decreased from 387 to 312 studies, 19% less than in 2016. The number of Phase IV trials increased in comparison with 2016 from 32 to 34 studies.

Patients

The number of subjects planned to be enrolled in Phase I-IV trials launched in 2017 is 55,903, 17% less than 2016 figure, when 67,385 subjects were planned to be enrolled.

Sponsors

Clinical trials in Russia in 2017 were sponsored by companies from 39 countries. The maximum number of trials (298) were initiated by Russian sponsors. American sponsors with 116 new studies took the runner-up place; they are followed by Swiss sponsors (55 trials), and Indian sponsors (45 trials).

Novartis is on the top of the heap of foreign pharmaceutical manufacturers in 2017 by sponsoring 25 new studies. They are followed by AstraZeneca and Merck & Co., having 17 new trials each, differentiating in number of patients, F.Hoffmann-La Roche with 15 new trials, and Dr. Reddy’s with 14 new studies in 2017.

Top five domestic pharmaceutical manufacturers by the number of new studies in 2017 is headed by Biocad, having 18 new trials. They are followed by North Star with 17 new trials, Microgen with 14 studies and Kanonpharma Production with 13 trials. Top five is concluded by Pharmasyntez with 11 studies.

Study Sites

The top five Russian research sites (BE and Phase I studies) in 2017 include: Medical Center Probiotec (33 new studies), Clinical Hospital N2, Yaroslavl (25 studies), Bioeq Ltd. and Ecosafety Ltd. (21 studies each) and Road Clinical Hospital at the station Yaroslavl of Russian Railways (17 new studies).

The top Russian research sites (Phase II-IV studies) include: Russian Oncological Scientific Center named after N.N. Blokhin (62 studies), Kazan State Medical University (54 studies), First Moscow State Medical University named after I.M. Sechenov (52 new studies) and First St. Petersburg State Medical University named after I.P. Pavlov (47 new studies).

Top Five CROs

The top five CROs in Russia are: Quintiles (27 new studies), PPD Development (15 studies), IPHARMA and Pharmaceutical Research Associates CIS (14 studies each), and Synergy Research Group (13 studies).

Therapy Areas

The top therapeutic areas were: Oncology (99 new studies), Therapy (48 studies), Hematology (47 studies) and Rheumatology and Neurology (42 studies each).

FDA and EMA Approvals

The Center for Drug Evaluation and Research (CDER) of the FDA approved 151 new drugs during 2017, and 30 of them were (or are being) studied in clinical trials conducted in Russia.

During 2017, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) gave positive recommendations on 94 new drug applications[1]. Fifty eight of the drugs which received positive opinions were (or are being) tested in clinical trials in Russia.

Need more information?

The Orange Paper is a free publication produced by Synergy Research Group for the pharmaceutical industry since 2007. It pulls together data from numerous public sources into a single brief document to aid decision makers planning to conduct clinical trials. It is produced quarterly, with an annual summary at the close of each year and can be downloaded here. The new version is coming soon. 

If you need information not covered in The Orange Paper, have suggestions to improve content, or wish to explore partnering with Synergy to speed up your clinical trial, please contact me directly.

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Igor Stefanov is CEO of Synergy Research Group, the World's First Agile Risk-Based Contract Research Organization, totally devoted to the Risk Based Thinking in Drug Development.