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Clinical Trials Review in Russia (September 2022)

In September 2022, there was a slight increase in the number of approved drug clinical trials compared to the previous month and a sharp decrease in the number of clinical trials compared to the same period in 2021 (more than 2 times).
Over the past six months, several major changes have been noted in the field of clinical trials in Russia, which were further confirmed by the results of the analysis of trials market in September 2022.
By September, it became clear that the rate of initiation of new drug clinical trials had slightly decreased: the figures for 2022 were lower than those for the same period in 2021 both in terms of the total number of trials and in the average monthly number of trials, and became closer to the data of 2019-2020 . At the same time, there is still a noticeable difference with the data of January-September 2018 (about 10 studies per month when assessing the first 9 months).
Since the beginning of 2022, the Ministry of Health of the Russian Federation has issued 576 approvals for drug clinical trials, which is 30 trials less than in the same period of 2021. At the same time, the number of foreign trials’ participants has significantly decreased (over the past 4 months, as in September, their share did not exceed 20% of the market).
As a result of the partial withdrawal of foreign pharmaceutical manufacturers, the work on import substitution of medicines has naturally become more active, especially at the level of drug development. In September, Russian sponsors initiated 80% of clinical trials, and the total number of domestic companies was 27. Among domestic sponsors, Promomed again became the leader in terms of the number of studies (10 clinical trials; 23% among Russian clinical trials). Domestic manufacturer of immunobiological grugs Microgen initiated 3 clinical trials (7%). It was noted that more than a half of the clinical trials of foreign sponsors fell on companies from India and Switzerland (3 clinical trials each).
More than 30% of clinical trials approved in September will be carried out with the involvement of contract research organizations.
In general, in recent months there has been a trend towards an increase in the proportion of volunteers participating in clinical trials. However, the September data showed a slightly different distribution of participants, with prevalence in the proportion of patients (this is partly due to the interpretation of participant status data in the two-stage COVID-19 drug study (see “Drug Studies” section above).
As it was noted above, the policy of drug import substitution in Russia leads to an increase in the number of clinical trials sponsored by domestic pharmaceutical manufacturers. Currently, these are mainly clinical trials of generics (in September, the share of CTs of generic drugs was more than 80%).
An analysis of the distribution of studies by phases in September 2022 also supports the trend towards an increase in the share of bioequivalence trials (68% of all initiated studies).
In September, no clinical trials of children's medicines were registered (a similar situation was also in April and June of this year). This may be partly due to the fact that bioequivalence studies, which are the majority, do not involve the pediatric population.
Among the drugs that will be studied in bioequivalence trials, anticoagulants are the most popular, and among non-bioequivalence trials, the largest number will be in the field of allergology. There is a significant decrease in trials associated with the development of drugs for the treatment of cancer.
Two more clinical trials of domestic drugs for the treatment of COVID-19 were registered. Thus, since the beginning of 2022, the total number of trials initiated for the prevention/treatment of COVID-19 has been 42 initiations.
In September 2022, there were no studies on biomedical cell products.
The situation in the field of medical device trials is somewhat different. As can be seen from the data presented in the report, in September 2022, the number of initiated clinical trials of medical devices exceeded the number of drug clinical trials by more than 2 times (121 and 55 clinical trials, respectively). Since the beginning of this year, the number of medical device clinical trials has been a record high compared to previous years of observation: Roszdravnadzor approved the start of 967 clinical trials, which is 18% more than in January-September 2021 and 31% more than in 2020 (whereas the number drug research in the first 9 months of the year decreased by almost 5%). When evaluating the indicator for the past period of 2022, the predominance of the number of studies of medical devices (967 and 576 trials) is also clearly visible.
The results of the distribution of medical device clinical trials across the Sponsor-country also remain stable: in 2022, the share of clinical trials of medical devices from foreign Sponsors did not decrease below 68% (and was 72% in September).