In 2016, OCT obtained approvals for the conduct of 12 new clinical trials. Thus, even without all the projects where sponsors made regulatory submissions independently, OCT is now rated as one of the most active contract research organizations in the region, alongside with Quintiles, PPD Development, Parexel and PRA CIS.
According to the Synergy Research Group report, a total of 895 new clinical trials from 39 countries were approved by the Ministry of Health of the Russian Federation in 2016, which is 12% higher than in 2015. The number of international multicenter trials (319) increased by 3% from the previous period, with the highest increase in the number of I phase trials (+51%).
It should be noted that the FDA Center for Drug Evaluation and Research approved more than 100 new medicinal products and that 27 of them were investigated as part of clinical trials conducted in Russia. At the same time, the Committee for Medicinal Products for Human Use of the EMA gave positive recommendations for 105 new medicines (71 of them studied in clinical trials in Russia as well).
“Such huge numbers demonstrate that the quality of clinical data in Russia meets all international standards for research studies. All this evidences the important role of our region for the whole industry. There is every reason to expect a continuous increase in the share of drugs studied in Russia and approved by FDA and EMA”, comments OCT President Dmitry Sharov.
In 2016, the most common therapeutic areas of clinical trials were oncology, neurology, therapeutics, and infection diseases. A similar trend is seen in portfolio of OCT, with more than 60 trials in oncology completed. Most of these are complex phase III studies.
To date, OCT has completed a total of 200 clinical trials.