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Clinical Trials Review in Russia (April 2021)

Data review on clinical trials in April 2021 demonstrates slight decrease in the number of approved drug clinical trials compared to the previous month and the noticeable increase compared to the corresponding period of 2020.
Like the previous months of the year, the total amount of trials and the monthly average in April remains the same - the parameters of 2021 are even closer to the ones of 2017 and are notably higher than these of 2018-2020.
The results of the first four months of 2017 and 2021 are 237 and 238 trials respectively, while in 2018-2020 the amount of trials in January-April was 200, 227 and 190 initiations. Comparing the average number of clinical trials in January-April of 2017–2021 the decrease of the parameter in 2018-2021 towards 2017 and 2021 is clearly seen (59,3, 50, 56,8, 47,5 and 59,3 trials per month through 2017–2021 respectively). So that, analyzing the first 4 months, in 2021 twelve more trials per month are initiated than it was in 2020.
The distribution by trial phase in April 2021 doesn’t differ much from the previous months except for the fact that there were no phase IV trials initiated. By other criteria, April 2021 doesn’t show any differences from the previous months of the year.
In April 2021 three drugs and one vaccine for treatment and prevention of COVID-19 were registered.
The number of initiated medical device trials has increased compared with the number of drug clinical trials (87 and 64 initiations respectively). Comparing this parameter through the first 4 months of 2021 the number of medical device trials still prevails (311 and 238 trials). It should be taken into consideration that the number of initiated medical device clinical trials has slightly decreased compared to last year: from 317 trials during the first 4 months of 2020 to 311 trials in the same period of 2021, however the number of drug clinical trials increased (190 trials in 2020 versus 238 trials in 2021).