myrwdРеальная клиническая практика: данные и доказательстваReal-World Data & Evidence2782-3784Publishing House OKI10.37489/2782-3784-myrwd-32WHBLHFmyrwd-37Research ArticleМЕЖДУНАРОДНЫЙ ОПЫТINTERNATIONAL EXPERIENCEДецентрализованные клинические исследования: регуляторные перспективы в России и ЕАЭСDecentralized clinical trials: regulatory perspectives in Russia and the EAEUhttps://orcid.org/0000-0002-6448-6973БорзоваМ. А.BorzovaM. A.

Борзова Мария Анатольевна — советник

РИНЦ AuthorID: 1203157

Москва

Borzova Maria A. — counsel

RSCI AuthorID: 1203157

Moscow

maria.borzova@gmail.comСеминаС. В.SeminaS. V.

Семина Софья Вадимовна — помощник адвоката

Москва 

Semina Sofia V. — paralegal

Moscow

sofyasemina18@gmail.comАдвокатское бюро «Трубор»Россия«Trubor» Law FirmRussian Federation202330082023321020Copyright © Борзова М.А., Семина С.В., 20232023Борзова М.А., Семина С.В.Borzova M.A., Semina S.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.myrwd.ru/jour/article/view/37

В статье описываются подходы к регулированию децентрализованных  клинических исследований (полностью или частично) в международной практике, а также в Российской Федерации и Евразийском экономическом союзе.

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.

децентрализованные клинические исследованияданные реальной клинической практикимеждународный регуляторный опытпациентоориентированный дизайн клинических исследованийзонтичные исследованиякорзинные исследованияdecentralized clinical trialsreal-world datainternational regulatory experiencepatient-centred clinical trial designumbrella trialsbasket trialsReferencesEuropean Commission’s Pharmaceutical Strategy for Europe. Доступно по адресу: https://health.ec.europa.eu/system/files/2021-02/pharma-strategy_report_en_0.pdf.European Commission’s Pharmaceutical Strategy for Europe. 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The authors declare that there are no conflicts of interest present.