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Decentralized clinical trials: regulatory perspectives in Russia and the EAEU

https://doi.org/10.37489/2782-3784-myrwd-32

EDN: WHBLHF

Abstract

This article describes regulatory approaches to the decentralized clinical trials (in whole or in part) in international practice, as well as in the Russian Federation and the Eurasian Economic Union.

About the Authors

M. A. Borzova
«Trubor» Law Firm
Russian Federation

Borzova Maria A. — counsel

RSCI AuthorID: 1203157

Moscow


Competing Interests:

The authors declare no conflict of interest.



S. V. Semina
«Trubor» Law Firm
Russian Federation

Semina Sofia V. — paralegal

Moscow


Competing Interests:

The authors declare no conflict of interest.



References

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3. European Medicines Agencies Network Strategy to 2025. Доступно по адресу: https://www.ema.europa.eu/en/documents/report/european-union-medicines-agencies-network-strategy-2025-protecting-public-health-time-rapid-change_en.pdf.

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7. Recommendation paper on decentralized elements in clinical trials. Доступно по адресу: https://health.ec.europa.eu/latest-updates/recommendation-paper-decentralised-elements-clinical-trials-2022-12-14_en.

8. Facilitating Decentralised Clinical Trials in the EU. Доступно по адресу: См. https://www.ema.europa.eu/en/news/facilitating-decentralised-clinical-trials-eu.

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10. Guidance for Industry, Investigators, and Institutional Review Boards: Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency. Доступно по адресу: https://www.fda.gov/media/136238/download.

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Review

For citations:


Borzova M.A., Semina S.V. Decentralized clinical trials: regulatory perspectives in Russia and the EAEU. Real-World Data & Evidence. 2023;3(2):10-20. (In Russ.) https://doi.org/10.37489/2782-3784-myrwd-32. EDN: WHBLHF

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ISSN 2782-3784 (Online)