Clinical approbation today: analysis of current problems and solutions

Objective: description of the current problems concerning the development and conducting of a protocol of clinical approbation (CA) of methods of prevention, diagnosis, treatment and rehabilitation to optimize the implementation of innovative medical technologies in practical health care through CA.
Material and methods. The review of the legislative framework governing CA and analysis of the proceedings of CA issues strategic session were carried out, management decisions to improve the effectiveness of CA were proposed. Analysis of legal acts stipulating the notion and status of CA was performed. The study included orders of the Ministry of Health of the Russian Federation, which established regulations on the organization of CA, the CA protocol templates, etc. Methodological materials, review articles on the organization of health care in the Russian Federation selected from various open sources were studied. The basis for making management decisions on improving the quality of CA procedure was formed by the participants of the CA issues strategic session which had been initiated by the Center for Healthcare Quality Assessment and Control.
Results. Based on the results of the strategic session and the analysis of legal acts, current issues related to CA regulation, such as lack of СА coordination and research publications, poor methodological quality of clinical and economic evaluations within CA, promotion of innovation through CA were identified. The developed managerial decisions on improvement of CA and promotion of innovations in practical health care were presented.
Conclusion. Current legal acts regulating CA activities should be updated with a view to establishing a transparent system of clinical and economic evaluations of new and innovative methods for making an informed decision to include them in clinical guidelines and routine clinical practice. It is proposed to legally assign the functions of CA coordinator to the federal medical development organizations. Regarding the promotion of innovative technologies in practical health care, it is advisable to create a system for the introduction of innovations, including taking into account conducting CA.

1. Khafizov I.I., Nurullin I.G., Sadykov Z.B. Features of the biotechnology industry in Russia and recommendations for improving the launch of innovative products to the market. PNRPU Bulletin. Chemical Technology and Biotechnology. 2017; 4: 19–36 (in Russ.). https://doi.org/10.15593/2224-9400/2017.4.02.

2. Ivanovskiy B.G. Innovation in healthcare: challenges of efficiency and implementation. Economic and Social Problems of Russia. 2021; 2: 143–60 (in Russ.). https://doi.org/10.31249/espr/2021.02.09.

3. Obukhova O.V., Brutova A.S., Dergachev A.V., Bazarova I.N. Approaches to the definition of specialized high-tech medical care. Medical Technologies. Assessment and Choice. 2018; 2: 42–7 (in Russ.).

4. Federal Law of 21.11.2011 No. 323-FZ “On the basics of public health protection in the Russian Federation” (with amendments and additions). Available at: https://base.garant.ru/12191967/ (in Russ.) (accessed 17.01.2023).

5. Federal Law of 08.03.2015 No. 55-FZ “On amendments to the Federal Law ‘On the basics of public health protection in the Russian Federation’ on the organization of medical care provided within the framework of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation”. Available at: https://base.garant.ru/70885196/(in Russ.) (accessed 17.01.2023).

6. Order of the Ministry of Health of the RF of 02.02.2022 No. 46n “On approval of the Regulations on the organization of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation and medical care within the framework of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation (including the procedure for referral of patients for such medical care), the standard form of the protocol of clinical testing of prevention methods, diagnostics, treatment and rehabilitation”. Available at: https://www.garant.ru/products/ipo/prime/doc/404656993/ (in Russ.) (accessed 17.01.2023).

7. Order of the Ministry of Health of the RF of 10.07.2015 No. 434n "On the Expert Council of the Ministry of Health of the Russian Federation on the organization of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation”. Available at: https://www.garant.ru/products/ipo/prime/doc/71048656/ (in Russ.) (accessed 17.01.2023).

8. Order of the Ministry of Health of the RF of 13.08.2015 No. 556 “On approval of Methodological recommendations for calculating the financial costs of providing medical care for each protocol of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation”. Available at: https://www.garant.ru/products/ipo/prime/doc/71064678/(in Russ.) (accessed 17.01.2023).

9. Center for Healthcare Quality Assessment and Control. Available at: https://rosmedex.ru/eng (accessed 17.01.2023).

10. Order of the Ministry of Health of the RF of 01.04.2016 No. 200n “On approval of the rules of good clinical practice”. Available at: https://www.garant.ru/products/ipo/prime/doc/71373446/ (in Russ.) (accessed 17.01.2023).

11. Khachatryan G.R., Luneva A.V. Characteristics of innovations in medicine and assessment of its value: a literature review. Medical Technologies. Assessment and Choice. 2013; 4: 23–9 (in Russ.).

12. Resolution of the Government of the RF of 28.08.2014 No. 871 “On approval of the Rules for the formation of lists of medicines for medical use and the minimum range of medicines necessary for the provision of medical care” (with amendments and additions). Available at: https://base.garant.ru/70728348/ (in Russ.) (accessed 17.01.2023).

13. Melikhov O.G. Clinical studies. 3rd ed. Мoscow: Atmosfera; 2013: 200 pp. (in Russ.).

14. Tolmachev A.V., Vostokova N.V. Development of the protocol of the registration clinical trial. Remedium. 2015; 4: 54–5 (in Russ.).

15. Khachatryan G.R., Ivakhnenko O.I., Sura M.V., Avxentyeva M.V. Assessment of the methodological quality of economic evaluations: main mistakes. Medical Technologies. Assessment and Choice. 2019; 1: 8–17 (in Russ.).

16. Baschinskiy S.E., Vlasov V.V., Vorobyev K.P., et al. Yerevan declaration on the consistent promotion of the principles of evidence-based medicine. Available at: https://www.clinvest.ru/jour/announcement/view/2222 (in Russ.) (accessed 17.01.2023).

17. Oslo Manual. Guidelines for collecting and interpreting innovation data. 3rd ed. Available at: http://www.physics.metu.edu.tr/~serhat/Oslo_Manual_Third_Edition.pdf (accessed 17.01.2023).

18. Grakovich A.A., Malakhova I.V., Kheifets N.E., Moskvicheva T.N. Principles of clinical and economic analysis and prospects for using its results in healthcare of the Republic of Belarus. Problems of Public Health Organization and Informatization. 2007; 2: 14–23 (in Russ.).

19. Omelyanovskiy V.V., Zheleznyakova I.A., Bezdenezhnykh T.P., et al. The review of the foreign experience on the financing of innovative medical technologies. FARMAKOEKONOMIKA. Sovremennaya farmakoekonomika i farmakoepidemiologiya / FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2020; 13 (3): 316–23 (in Russ.). https://doi.org/10.17749/2070-4909/farmakoekonomika.2020.055.