Risks of clinical approbation protocols for medical technologies: classification and assessment based on obstetric and gynecological protocols

Background. Clinical approbation is one of the mechanisms for introducing new medical technologies into practical healthcare, including them in clinical guidelines and, subsequently, in the public financing system.
Objective. To identify and classify the risks inherent in clinical approbation protocols and to propose a tool for their assessment at the protocol preparation stage.
Materials and Methods. A descriptive, analytical, and content analysis study was conducted. Three 2022 obstetric and gynecological protocols from the register of implemented protocols of the Russian Ministry of Health (2015–2026) were reviewed. Risks were grouped into eight areas, and a risk diagram and a weighted summary risk index (0–30) were constructed for each protocol.
Results. Methodological, documentary, safety, organizational, technological, economic, translational, and legal risks were identified. According to the developed index (0–30), the radiofrequency protocol (19) has a higher risk due to documentation discrepancies and technological dependence. The indices for the rehabilitation and surgical protocols were 16 and 11, respectively. All three protocols were classified as moderate risk. Technological dependence and the risk of overstating conclusions were common to all protocols. A risk mitigation checklist for each area is proposed.
Conclusion. The clinical trial protocol is a source of manageable implementation risks, a significant portion of which are identified at the document level before the results are obtained. The scoring and checklist allow for the early identification of protocol vulnerabilities. Protocol readiness is not the same as implementation: only 13.81% of tested methods are included in clinical guidelines, on average after 2–3 years.

1. Clinical approbation: materials of the Center for Healthcare Quality Assessment and Control of the Ministry of Health of Russia. (In Russ.)

2. Implemented clinical approbation protocols: official website of the Ministry of Health of the Russian Federation. (In Russ.)

3. Gabrielyan A.R., Aleksandrova O.Yu., Mikhaylov I.A. Rezul’taty analiza vklyucheniya innovatsionnykh tekhnologiy v ramkakh klinicheskoy aprobatsii v klinicheskie rekomendatsii. Remedium. 2025;29(1):10–13. https://doi.org/10.32687/1561-5936-2025-29-1-10-13 (In Russ.)

4. Omel’yanovskiy V.V., Luk’yantseva D.V., Alekseeva T.I., et al. Klinicheskaya aprobatsiya segodnya: analiz tekushchikh problem i puti ikh resheniya. Farmakoekonomika. Sovremennaya farmakoekonomika i farmakoepidemiologiya. 2023;16(1):60–69. https://doi.org/10.17749/2070-4909/farmakoekonomika.2022.168 (In Russ.)

5. Starodubov V.I., Kadyrov F.N., Perkhov V.I., Obukhova O.V. Okazanie meditsinskoy pomoshchi v ramkakh klinicheskoy aprobatsii. Menedzher zdravookhraneniya. 2015;(9):63–76. URL: https://cyberleninka.ru/article/n/okazanie-meditsinskoy-pomoschi-v-ramkah-klinicheskoy-aprobatsii/viewer (10.05.2026 г.) (In Russ.)

6. Starodubov V.I., Perkhov V.I., Kadyrov F.N., Yankevich D.S. Problemy okazaniya meditsinskoy pomoshchi v ramkakh klinicheskoy aprobatsii. Kompleksnye problemy serdechno-sosudistykh zabolevaniy. 2016;(1):26–30. https://doi.org/10.17802/2306-1278-2016-1-26-30 (In Russ.)

7. Gabrielyan A.R., Aleksandrova O.Yu., Mikhaylov I.A. Analiz razrabotannykh innovatsionnykh tekhnologiy v ramkakh klinicheskoy aprobatsii po profilyam meditsinskoy pomoshchi. Byulleten’ Natsional’nogo NII obshchestvennogo zdorov’ya imeni N.A. Semashko. 2025;(1):64–69. https://doi.org/10.69541/NRIPH.2025.01.010 (In Russ.)

8. Clinical approbation protocol of the comprehensive rehabilitation program for chronic pelvic pain in women of late reproductive and perimenopausal age for conservative non-drug treatment compared with Kegel exercises (registration material 2022-21-7). National Medical Research Center for Rehabilitation and Balneology of the Ministry of Health of Russia. Moscow, 2022. URL: https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/059/720/original/2022-21-7.pdf?1653472556 (08.05.2026) (In Russ.)

9. Clinical approbation protocol of the method for treatment of anterior and/or posterior vaginal wall prolapse stage I–II using dynamic quadripolar radiofrequency (registration material 2022-52-7) / Ural Research Institute for Maternal and Child Care of the Ministry of Health of Russia. Yekaterinburg, 2022. URL: https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/059/730/original/2022-52-7.pdf?1653472564 (10.05.2026). (In Russ.)

10. Clinical approbation protocol of the method of laparoscopic hysterectomy using a uterine manipulator with a colpotransillumination system (registration material 2022-53-1) / National Medical Research Center for Obstetrics, Gynecology and Perinatology named after V. I. Kulakov of the Ministry of Health of Russia. Moscow, 2022. URL: https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/059/727/original/2022-53-1.pdf?1653472564= (10.05.2026) (In Russ.)

11. On approval of the Regulation on the organization of clinical approbation and the standard form of a clinical approbation protocol: Order of the Ministry of Health of the Russian Federation No. 245n of 19.05.2023. URL: http://publication.pravo.gov.ru/document/0001202306140013 (10.05.2026). (In Russ.)

12. On approval of methodological recommendations for calculating financial costs for each clinical approbation protocol: Order of the Ministry of Health of the Russian Federation No. 556 of 13.08.2015. URL: https://rosmedex.ru/approbation (10.05.2026). (In Russ.)

13. On repeal of Order No. 200n of 1 April 2016 on the Rules of Good Clinical Practice: Order of the Ministry of Health of the Russian Federation No. 274n of 29.05.2024. URL: http://publication.pravo.gov.ru/document/0001202407040010 (дата обращения: 10.05.2026). (In Russ.)

14. Shifrin Yu.A., Tuzova E.A., Makhrova A.A., Shutova A.D., Blinov D.S., Karachunskiy A.I. Stoimost’ terapii ostrogo limfoblastnogo leykoza u detey s primeneniem kombinirovannoy khimio- i immunoterapii: sravnenie raschetnykh i real’nykh znacheniy. Acta Medica Eurasica. 2024;(1). https://doi.org/10.47026/2413-4864-2024-1-38-49 (In Russ.)

15. On the Fundamentals of Protecting the Health of Citizens in the Russian Federation: Federal Law No. 323-FZ of 21.11.2011, Art. 36.1. URL: http://pravo.gov.ru (10.06.2026 (In Russ.)