The Russian Association of Clinical Trials Organization (ACTO) published a comparative study of compliance checks FDA conducts worldwide. Used in the study were the results of clinical trial inspections in the period from 1995 to the first half of 2015. The analysis revealed that in Russia the number of clinical studies conducted with no admonition from the FDA check inspections was on average 28% higher than in European countries (Germany, France, and Great Britain).
Here are more precise percentages of clinical studies per countries which were conducted without admonition from the FDA:
- Russia – 66 %
- Germany – 44%
- France – 37%
- Britain – 33%.
Severe breaches were registered in 1% of cases in Russia, Germany and France, and in 2% – in the UK. It should be noted that the number of inspections conducted in developed European countries and Russia during the mentioned period of 20 years doesn’t differ much. In Germany, for instance, during the reporting period, FDA conducted 108 inspections, in Russia – 100, in the UK – 99, and 84 in France.
Moreover the Center of Drug Evaluation and Research (CDER) of the FDA approved 123 new drugs during 2015, and 50 of them were (or are being) studied in clinical trials conducted in Russia. The Committee for Medical Products for Human Use (CHMP) of the European Medicine Agency (EMA) gave positive recommendations on 113 new drug applications. 71 of the drugs, which received positive opinions we (or are being) tested in clinical trials in Russia.
The high quality of clinical trials in Russia was also confirmed by the results of inspections conducted by Russian state control bodies. According to Roszdravnadzor (Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation), only 31% of the organizations that conducted clinical studies in 2014 made mistakes or violations in their work. As a rule, all these errors referred to document maintenance and had no effect on the authenticity of clinical study results or patients’ health.
According to Roszdravnadzor, there are 1127 registered medical facilities in Russia accredited to conduct clinical research, while only 700 of those facilities really conduct them. During the first half-year period of 2015, the Ministry of Health of the Russian Federation issued 347 permits for conducting medical research. This number is only 4.4% smaller than that for the same period of 2014, which is an indication of this market stability.