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Clinical Trials Review in Russia (May 2021)

Data review on clinical trials in May 2021 demonstrates strong decrease in the number of approved drug clinical trials compared to the previous month and slight decrease compared to the corresponding period of 2020.
Because of the sharp decrease in the number of approved drug clinical trials in May 2021, the total amount of trials and the monthly average have changed - the parameters of 2021 became closer to the ones of 2018–2020 and were lower than these of 2019.
The result of the first 5 months of 2021 is 294 trials, while in 2019 there were 283 trials initiated, while in 2018, 2020 and 2021 the amount of trials in January-May was 261, 2255 and 267 trials respectively. Comparing the average number of clinical trials in January-May of 2017–2021 the decrease of the parameter in 2018, 2020 and 2021 towards 2017 and 2019 is clearly seen (58,8, 52,2, 56,6, 45,0 and 53,4 trials per month through 2017–2021 respectively).
The distribution by trial phase in May 2021 doesn’t differ much from the previous months: phase III and bioequivalence studies prevail, making together 69% of the total drug clinical trials approved. As in the previous month, in May 2021 there were no phase IV trials. Also, there were no trials involving underage subjects, for the first time since March 2020.  By other criteria, May 2021 doesn’t show any differences from the previous months of the year.
In May 2021 two more drug clinical trials for COVID-19 treatment were registered. So that, the total amount of drug trials for treatment and prevention of COVID-19 during the first 5 months of the year is 21 initiations.
In May 2021 the number of initiated medical device trials has trice increased the number of drug clinical trials (82 and 29 initiations respectively). Comparing this parameter through the first 5 months of 2021 the number of medical device trials still prevails (393 and 267 trials). It should be taken into consideration that the number of initiated medical device clinical trials didn’t change significantly compared to last year: from 383 trials during the first 5 months of 2020 to 393 trials during the same period of 2021 (slight increase by 2,5%), however the number of drug clinical trials increased by 16%.