Сравнительный анализ критериев проведения клинических испытаний лекарственных средств в Российской Федерации, Соединённых Штатах Америки и Европейском Союзе

Здравоохранение Российской Федерации. 2023. Т. 67. № 1. С. 78–84.

Лебедева Д. А.

Introduction. As a part of the admissions to the market for medicines, there are requirements and restrictions that apply to the application of the “risk-based approach”. Requirements differ by subject, object of the tstudy, individual characteristics. The author carried out a comparative legal analysis of the requirements and criteria established by the legislation of the Russian Federation, USA, and EU.

The purpose of the study is to identify criteria, limitations in the process of conducting clinical trials of medicines involving humans.

Material and methods. The author studied the Russian legislation in the field of restrictions on clinical trials of preparations and analyzed the relevant experience of the USA and EU. Methods of structural analysis, logical generalizations, classifications, comparative legal method were used.

Results. The Russian regulation of drug trials provides for a fairly wide and complete list of restrictions and requirements that contribute to the implementation of a risk-based approach. At the same time, EU and USA legislation is more focused on protecting the rights of participants under study, Russian standards must be supplemented in terms of work with minors during clinical trials. The Russian legal model of clinical trials may develop in the area of liberalizing restrictions and establishing more detailed the procedure for participation in the clinical trials of certain categories of persons.

Limitations. This article is compiled on the basis of 67 sources available to the author (student libraries, Russian databases of articles and journals). The study is limited to a sample of 27 sources, of which 10 are normative acts on the topic of work.

Conclusion. The article develops criteria for comparing the limitations of clinical trials of medicines in the Russian Federation, USA and EU, and suggests recommendations for improving the Russian regulatory model. A transparent range of requirements for conducting clinical trials ensures the safety for the population, including certain categories of people. Russian regulation should be improved in terms of ensuring the protection of the rights of the maximum number of participants, depending on national priorities, taking into account the best foreign practices.

Keywords: медицинские клинические исследования, обращение лекарственных средств, правовые ограничения, информированное согласие, биоэтика, bioethics, Clinical trials, informed consent, drug circulation, legal restrictions