myrwdРеальная клиническая практика: данные и доказательстваReal-World Data & Evidence2782-3784Publishing House OKI10.37489/2782-3784-myrwd-17WRSZFTmyrwd-21Research ArticleМЕЖДУНАРОДНЫЙ ОПЫТINTERNATIONAL EXPERIENCEАнализ рекомендаций и руководств по RWD/RWE за 2021 год. Международный опыт на примере СШАAnalysis of RWD/RWE recommendations and guidelines for 2021. International experience on the example of USAhttps://orcid.org/0000-0003-3031-4572КурылевА. А.KurylevA.

Курылев Алексей Александрович — к. м. н., ассистент кафедры клинической фармакологии и доказательной медицины

Санкт-Петербург

Kurylev Alexey A. — Cand. Sci. Med., Assistant of professor Department of Clinical Pharmacology and Evidence-Based Medicine

Saint-Petersburg

alexey-kurilev@yandex.ruФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет имени И. П. Павлова»; ФГБУ «Национальный исследовательский центр онкологии им. Н. Н. Петрова» Минздрава РоссииРоссияFirst Saint-Petersburg State Medical University Named After Academician Pavlov; National Research Center of Oncology named after N. N. PetrovRussian Federation2022171120222316Copyright © Курылев А.А., 20222022Курылев А.А.Kurylev A.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/21

Регулирование проведения исследований реальной клинической практики, которые представляются регуляторам разных стран, для обоснования принятия регуляторных решений в отношении лекарственных препаратов в последние годы приобретает особенную актуальность. Во втором полугодии 2021 года FDA выпустило проекты 3 документов, регулирующих особенности проведения исследований реальной клинической практики. В статье приводятся основные положения и подходы, изложенные в документах FDA. Рассмотренные документы представляют собой международный опыт, которые может быть использован в разработке локальных рекомендаций.

The regulatory aspects of the conduction of the real-world clinical data studies became a trend in the past few years. In 2021 FDA issued three projects of such documents. The article resumes the main objectives of these FDA documents. Analysed projects of FDA recommendations represents the international expertise in this field and may be used in the process of building local regulations.

исследования реальной клинической практикиFDAруководствоэлектронные медицинские картыreal-world clinical practiceFDArecommendationelectronic medical recordsReferencesReal-World Data:Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry. DRAFT GUIDANCE. https://www.regulations.gov/document/FDA-2020-D-2307-0002.Real-World Data:Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry. DRAFT GUIDANCE. https://www.regulations.gov/document/FDA-2020-D-2307-0002.Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry.DRAFTGUIDANCE. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-registries-support-regulatory-decision-making-drug-and-biological-products?utm_medium=email&utm_source=govdelivery.Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry.DRAFTGUIDANCE. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-registries-support-regulatory-decision-making-drug-and-biological-products?utm_medium=email&utm_source=govdelivery.Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry. DRAFT GUIDANCE. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug.Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry. DRAFT GUIDANCE. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug.Best Practices for Conducting and Reporting Pharma- coepidemiologic Safety Studies Using Electronic Healthcare Data Sets. https://www.fda.gov/media/79922/download.Best Practices for Conducting and Reporting Pharma- coepidemiologic Safety Studies Using Electronic Healthcare Data Sets. https://www.fda.gov/media/79922/download.

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