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Clinical Trials Review in Russia (July 2022)

In July 2022, there was a decrease in the number of approved drug clinical trials by 23% compared to the previous month and by 40% compared to July 2021.
Data review for the first 7 months of 2018 - 2022 showed that both in terms of the total number of studies and the average monthly number of studies, the results of 2022 significantly exceed those of 2018 (this year, almost 100 more clinical trials were approved in January-July, and on average 13 more clinical trials were initiated per month than for the same period in 2018). Predominance of 2022 results over 2019-2021 indicators less pronounced. At the same time, the results of 2019–2021 became even closer to each other both in terms of the total number of studies and the average monthly number of studies.
In July, the share of foreign sponsors among the initiators of new clinical trials continued to decline. Thus, over the past month, only 17% of clinical trials were approved, which will be carried out with the support of foreign pharmaceutical companies. This became a record negative indicator of the participation of foreign companies for the entire period of maintaining the Register of Clinical Trials (since 2014) and updated the "anti-record" of June 2022. Among the countries whose representatives are foreign companies that continued conducting clinical trials in Russia, Switzerland was in the lead in July.
The ratio of clinical trials in terms of the number of original and generic drugs in July is similar to the situation last month: only 1 out of 5 trials will study original molecules (19% of the total number of approved trials). The ratio of CT participants also did not differ significantly from June 2022, and two-thirds of the subjects in the planned CTs will be volunteers.
The distribution of the number of studies by phases in July maintains the emerging trend of the previous months - the share of bioequivalence studies significantly dominates (68% of all initiated clinical trials), while the presence of phases I and III studies is equal to each other (15% each).
The share of trials in which multicomponent drugs will be studied became the largest in 7 months of 2022 and amounted to 19%.
In July, no trials of drugs for the prevention and treatment of COVID-19 and trials of biomedical cell products were registered.
The situation with studies of medical devices remains more stable compared to CTs of drugs. In June, Roszdravnadzor approved 113 clinical trials of medical devices, which is almost 2.5 times more than the number of initiated clinical trials of drugs. However, when assessing the indicators for the first 7 months of 2022, the difference between them is smoothed out, and the predominance of research on medical devices is less pronounced (1.5 times - 738 and 472 trials, respectively).
At the same time, the number of initiated trials of medical devices increased compared to the previous year: from 579 trials in January-July 2021 to 738 trials in the same period of 2022, that is, an increase of approximately 22% (whereas the number of drug trials for this time increased by 14%.
The ratio between sponsors of clinical trials of medical devices in July also does not differ significantly from the previous months of the year. Data analysis consistently shows the prevalence of research on medical devices sponsored by foreign manufacturers (in July 2022, this figure reached 80%).