myrwdРеальная клиническая практика: данные и доказательстваReal-World Data & Evidence2782-3784Publishing House OKI10.37489/2782-3784-myrwd-18LVXISJmyrwd-22Research ArticleМЕЖДУНАРОДНЫЙ ОПЫТINTERNATIONAL EXPERIENCEИспользование данных реальной клинической практики при принятии решений в Канаде и ВеликобританииUse of real-world data for decision making in Canada and United Kingdomhttps://orcid.org/0000-0001-7261-3461МухортоваП. А.MukhortovaP. A.

Мухортова Полина Алексеевна — ведущий специалист отдела методологического обеспечения проведения комплексной оценки технологий в здравоохранении

Москва

Mukhortova Polina A. — Leading Specialist of the Department of Methodological Support for Comprehensive Assessment of Technologies in Healthcare 

Moscow

muhortova@rosmedex.ruhttps://orcid.org/0000-0002-4586-2451ГоркавенкоФ. В.GorkavenkoP. V.

Горкавенко Филипп Васильевич — заместитель начальника отдела методологического обеспечения проведения комплексной оценки технологий в здравоохранении

Москва

Gorkavenko Philip V. — Deputy Head of the Department of Methodological Support for Compre- hensive Assessment of Technologies in Healthcare

Moscow

fill-gor@yandex.ruhttps://orcid.org/0000-0002-6751-2903СтрунинаЮ. В.StruninaYu. V.

Струнина Юлия Витальевна — начальник отдела методологического обеспечения проведения комплексной оценки технологий в здравоохранении

Москва

Strunina Yulia V. — Head of the Department of Methodological Support for Comprehensive Assessment of Technologies in Healthcare

Moscow

strunina@rosmedex.ruhttps://orcid.org/0000-0003-1581-0703ОмельяновскийВ. В.OmelyanovskiyV. V.

Омельяновский Виталий Владимирович — генеральный директор; руководитель Центра финансов здравоохранения; заведующий кафедрой экономики, управления и оценки технологий здравоохранения, д. м. н., профессор

Москва

Omelyanovskiy Vitaly V. — General Director; Head of the Center for Healthcare Finance; Head of the Department of Economics, Management and Evaluation of Health Technologies, MD, Professor

Moscow

office@rosmedex.ruhttps://orcid.org/0000-0002-7996-6953КалиниченкоВ. В.KalinichenkoV. V.

Калиниченко Вадим Валентинович — заместитель начальника аналитического отдела

Москва

Kalinichenko Vadim V. — Deputy Head of the Analytical Department

Moscow

kalinichenkoVV@minzdrav.gov.ruФГБУ «Центр экспертизы и контроля качества медицинской помощи» Министерства здравоохранения Российской ФедерацииРоссияCenter for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian FederationRussian FederationФГБУ «Центр экспертизы и контроля качества медицинской помощи» Министерства здравоохранения Российской Федерации; ФГБУ «Научно-исследовательский финансовый институт» Министерства финансов Российской Федерации; ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Министерства здравоохранения Российской ФедерацииРоссияCenter for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation; Financial Research Institute of the Ministry of Finance of the Russian Federation; Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of the Russian FederationRussian Federation20221711202223719Copyright © Мухортова П.А., Горкавенко Ф.В., Струнина Ю.В., Омельяновский В.В., Калиниченко В.В., 20222022Мухортова П.А., Горкавенко Ф.В., Струнина Ю.В., Омельяновский В.В., Калиниченко В.В.Mukhortova P.A., Gorkavenko P.V., Strunina Y.V., Omelyanovskiy V.V., Kalinichenko V.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/22

В статье представлен обзор подходов к использованию данных реальной клинической практики (РКП) в области регистрации и оценки технологий здравоохранения в Канаде и Великобритании, а также краткое описание инструментов для принятия управленческих решений в области здравоохранения — Канадского сотрудничества по использованию доказательств, полученных на основе данных реальной клинической практики в области онкологии, электронных баз данных и регистров. Представлена информация о том, в каких случаях возможно и рекомендовано представление данных РКП и какие требования к данным РКП и доказательствам на их основе предъявляют регуляторные агентства.

This article provides an overview of approaches to the use of real-world data (RWD) and real-world evidence (RWE) in the processes of registration and health technology assessment in Canada and the UK, as well as a brief description of tools for health management decision-making, the Canadian Real-world Evidence for Value in Cancer Collaboration and electronic databases and registries. Information is provided on when RWE submission is possible and recommended, and what requirements the regulatory agencies have for RWD and RWE.

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The authors declare that there are no conflicts of interest present.