Apr 26, 2021
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“Nobody cares”: most clinical trials in Russia are conducted without the approval of the Ministry of Health

In the study, published in the journal BMC Medical Ethics, scientists searched the Russian-language eLIBRARY database and selected 26 articles that described the results of clinical trials of various drugs with the participation of volunteers. They then compared the findings with the national registry of approved clinical trials to determine whether each drug was approved for sale in Russia, and whether the indications, dosage, and route of administration used during the trials were consistent with the approved label. The authors of the study also checked the presence of advertisements for drugs in all articles.

The results showed that 22 out of 26 drug trials were carried out unauthorized, that is, without the approval of the Ministry of Health, and three of them were carried out on children. Although in 21 out of 22 cases the study drug was registered in Russia, in nine cases the therapeutic indications, dosage and route of administration did not meet the conditions indicated on the label.

“Moreover, in one case, an unauthorized trial involved a drug therapy intervention when an active ingredient was not approved for use in any drug marketed in Russia. In 14 out of 26 articles, the journal issue or the article itself contained an advertisement for the same drug or, in one case, its manufacturer. All publications, accompanied by advertising, claimed that the drug in question was effective, ”the authors of the study said.

On his Facebook page, Peter Talantov wrote that “the study does not pretend to be a comprehensive study of the issue, it is only a first glance at the problem.” The authors did not set themselves the goal of studying the reasons, but the expert suggested that the first of them is related to the fact that “no one cares”.

“If the research is not carried out as part of the registration of a medicinal product, there is no control in any form by the regulator. The Ministry of Health pretends that this does not concern them, ”explained Talantov. According to him, the ministry simply refuses to do this part of its work.

Among other possible reasons, scientists attributed the lack of pressure and control from the professional community, and in such conditions it is easier not to obtain permission.

“If only because it would not be possible to justify the expediency of conducting a study in all cases. One gets the impression that a significant part of the research is carried out not to answer a scientific question, but, for example, to achieve marketing goals, ”the scientist believes.

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