The number of clinical trials of new drugs may decrease in Russia

The number of clinical trials (CI) of medicines in Russia may decrease in the near future, and the time frame for registration of new drugs may be stretched, representatives of the pharmaceutical market told Izvestia. In their opinion, this may result from the adoption of a draft law developed by the Ministry of Health. According to it, pharmaceutical companies are prohibited from making direct payments to doctors for participating in clinical trials. They are proposed to be conducted through medical organizations where doctors work.

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Amendments regarding the conduct of clinical trials will make it difficult to conduct them and lead to a reduction in their number in Russia, the Association of pharmaceutical companies Infarma said in a letter to the Ministry of Health. The Association of Pharmaceutical Manufacturers of the Eurasian Economic Union told Izvestia that if the amendments are adopted, the timing of the CI will also slow down. According to a retrospective analysis of the association based on 50 CI, the adoption of amendments may delay the start of the study and the receipt of therapy by patients by an average of one month, the receipt of research data by three months, and the registration of drugs by four months.

"Currently, it takes an average of 3-7 days to conclude an agreement with an individual. The conclusion of an agreement with a legal entity takes one and a half months. The deadlines for the development, submission of medical documentation and launch of AI will be shifted. This will also affect the rate of patient recruitment, the involvement of specialists and, as a result, the speed of research will slow down," the association explained.

According to the explanatory note to the draft law developed by the Ministry of Health, the amendments "are aimed at minimizing the risk of a conflict of interest among researchers and ensuring their independence from interested parties when conducting research."

The document also notes that "the bill will not have a negative impact on the organization and conduct of clinical trials in general and does not affect the rights and legitimate interests, including participants, organizers of clinical trials, researchers and co-researchers."

Read more in the Izvestia article:

Proven means: the number of clinical trials may decrease in the Russian Federation