The State Of Clinical Trials In Russia
By John Barker, COO, Synergy Research Group
Every quarter, Synergy Research Group, a full-service CRO headquartered in Moscow, Russia, issues its Orange Paper. The report, which looks at the state of clinical trials in Russia, is comprised of research done by combing through data from the country’s Ministry of Health. The Orange Paper offers a concise snapshot of clinical trials in the region.
The Q2, 2014 Synergy Orange Paper was just released. One of the more significant findings is that the gap between previous years’ trials and the current period is closing. In the first quarter of 2014, there were 18 percent fewer trials than in the same quarter in 2013. In the second quarter, there was a gap of only three percent.
 |
| Igor Stefanov, CEO, Synergy Research Group |
Synergy’s CEO, Igor Stefanov, said, “We started publishing the Orange Paper because clinical research in Russia is a dynamic marketplace that is increasingly attractive globally. Having detailed information on the state of clinical research in the region allows sponsors to make better informed decisions.”
Looking at numbers, Synergy found that The Ministry of Health of Russian Federation approved 194 new clinical trials of all types including local and bioequivalence studies during the 2nd Quarter of 2014 (three percent less than at the same period of the last year).
The Q2 Synergy Orange Paper showed that the main contribution to the total number of studies was made by multinational, multi-center clinical trials (MMCT) and the number of these studies stayed the same as in Q2 2013 – 81 studies. The number of bioequivalence studies (BE) decreased from 76 studies in Q2 2013 to 59 in Q2 2014, a 22 percent decrease from last year’s figure. The number of local clinical trials (LCT) increased from 42 in Q2 2013 to 54 clinical trials in Q2 2014.
The share of multinational, multi-center clinical trials was 42 percent of the total number of clinical trials in Q2 2014, while bioequivalence and local studies amounted to 30 percent and 28 percent respectively. Clinical trials in Russia in Q2 2014 were sponsored by companies from 24 countries.
The highest number of trials (89) was initiated by Russian sponsors. American sponsors followed with 29 new studies. German and UK sponsors tied with 11 trials each, Swiss sponsors with ten studies and Israeli sponsors with nine new studies. The group of leaders is rounded out by French sponsors having seven studies.
The number of Phase I clinical trials remained about the same and stood at eight new studies in Q2 2014. The number of the Phase II trials increased from 21 in Q2 2013 to 29 new studies in Q2 2014. The number of Phase III trials increased from 88 to 92 studies, 5 percent more than in Q2 2013. Phase IV trials showed an increase from five studies in Q2 2013 to six studies in Q2 2014.
The number of subjects planned to be enrolled in Phase I-IV trials launched in Q2 2014 is 15,424. That number is 22 percent more than in Q2 2013 figure, when 12,677 patients were planned to be enrolled.
GlaxoSmithKline sponsoring six new studies is on the top of the heap in Q2 2014. It is followed by Janssen, Pfizer, Merck & Co. and Amgen each having four new trials in Q2 2014 and differing in the number of patients.
The top five Russian pharmaceutical manufacturers in Q2 2014 were: Microgen, EcoPharmPlus, OOO Atoll, Petrovax and Trivium-XXI, each having two new trials and differing in the number of patients.
82 percent of new studies in Q2 2014 were initiated in eight leading therapeutic areas:
- Oncology, Pulmonology and Musculoskeletal diseases led with 16 studies each.
- Infectious, Parasitic and Circulatory system diseases each had 14 new studies.
- Digestive system disease and Endocrinology each had 12 new studies in Q2 2014.
- Hematology had seven new studies.
Russia was chosen as a clinical trial location for a large number of new pharmaceuticals. The Center for Drug Evaluation and Research (CDER) of the FDA approved 25 new drugs during Q2 2014 - 10 of them were (or are being) studied in clinical trials conducted in Russia.
During the second quarter of 2014 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMEA) gave positive recommendations on 28 new drug applications. 18 of the drugs which received positive opinions were (or are being) tested in clinical trials in Russia.
Russia has lower per-patient costs and faster time for approvals. The country is also experiencing a growth in per capita spending and is expected to rise from 11th place to eighth place in the global pharmaceutical market, according to Thomson Reuters. Experienced, stable CROs and access to a high number of investigators will continue to make Russia a strong option for outsourced clinical trials. To download the Synergy Orange Paper, visit http://www.synrg-pharm.com/.