myrwdРеальная клиническая практика: данные и доказательстваReal-World Data & Evidence2782-3784Publishing House OKI10.37489/2782-3784-myrwd-6.FZCZWCmyrwd-8Research ArticleАКТУАЛЬНЫЕ ОБЗОРЫACTUAL REVIEWКраткий отчёт о развитии доказательств, основанных на данных реальной клинической практики (RWD/RWE) в 2021 году: США, Россия и Евразийский экономический союз (ЕАЭС)A brief report of real-world evidence development (RWD/RWE) in 2021: United States, Russia, and the Eurasian Economic Union (EAEU)https://orcid.org/0000-0002-1919-2909КолбинА. С.KolbinA. S.

Колбин Алексей Сергеевич – д. м. н., профессор, заведующий кафедрой клинической фармакологии и доказательной медицины; профессор кафедры фармакологии медицинского факультета Санкт-Петербургского государственного университета 

Санкт-Петербург

Kolbin Alexey S. – Dr. Sci. (Med.), Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine; professor of the Department of Pharmacology, Medical Faculty, St. Petersburg State University 

St. Petersburg

alex.kolbin@mail.ruhttps://orcid.org/0000-0002-2164-8290БелоусовД. Ю.BelousovD. Yu.

Белоусов Дмитрий Юрьевич – Генеральный директор 

Москва

Belousov Dmitry Yu. – CEO 

Moscow

clinvest@mail.ruФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет им. академика И. П. Павлова» Министерства здравоохранения Российской ФедерацииРоссияFSBEI HE I. P. Pavlov SPbSMU MOH RussiaRussian FederationООО «Центр фармакоэкономических исследований»РоссияLLC «Center for Pharmacoeconomics Research»Russian Federation2022300120222119Copyright © Колбин А.С., Белоусов Д.Ю., 20222022Колбин А.С., Белоусов Д.Ю.Kolbin A.S., Belousov D.Y.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/8

В статье представлен краткий обзор основных событий по развитию парадигмы данных реальной клинической практики и доказательств (Real-world data и Real-world evidence, RWD/RWE) в США, России и Евразийском экономическом союзе (ЕАЭС) в 2021 году. Обзор составлен в календарной последовательности. Сначала представлены события в США, источником которых является информационный ресурс The Evidence Base. Затем — данные по Российской Федерации и ЕАЭС, аккумулированные на странице Facebook «myRWD — Реальная Клиническая Практика» и в журнале «Реальная клиническая практика: данные и доказательства» (Real-World Data & Evidence). Информация суммируется, и даётся полное представление о развитии реальной клинической практики и её доказательств в указанных странах. 

The article provides a brief overview of the main trends in the development of real-world data and real-world evidence (RWD/RWE) paradigm in the United States, Russia, and the Eurasian Economic Union (EAEU) in 2021. The review is compiled in calendar sequence. First, events in the United States are presented, sourced from the information resource, "The Evidence Base". Following this, data for the Russian Federation and the EAEU are collected and stored on the "myRWD — Real Clinical Practice" Facebook page, and in the journal "Real-World Data & Evidence". The information is summarized and a complete picture of the development of real clinical practice and its evidence in the indicated countries is given.

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MD, USA, 2021.Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products. US FDA. MD, USA, 2021.Kolbin AS. Resolution based on the results of the conference: «RWD/ RWE — Research Tools of Real-World Clinical Practice Today and Tomorrow». Real-World Data & Evidence. 2021;1(1). https://doi.org/10.37489/2782-3784-myrwd-5.Kolbin AS. Resolution based on the results of the conference: «RWD/RWE — Research Tools of Real-World Clinical Practice Today and Tomorrow». Real-World Data & Evidence. 2021;1(1). https://doi.org/10.37489/2782-3784-myrwd-5.Итоговая резолюция по результатам работы симпозиума «Фармакоэкономика в онкологии». Режим доступа: https://forum-onco.ru/media/itogovaya-rezolyutsiya-po-rezultatam-rabotysimpoziuma-farmakoekonomika-v-onkologii/#news.Final resolution on the results of the symposium "Pharmacoeconomics in oncology". (In Rus.) Режим доступа: https://forum-onco.ru/media/itogovaya-rezolyutsiya-po-rezultatam-raboty-simpoziuma-farmakoekonomika-v-onkologii/#news.В Общественной палате РФ состоялось экспертное обсуждение проблем цифровизации здравоохранения. Режим доступа: https://bm24.ru/obshchestvo/v_obshchestvennoy_palate_rf_sostoyalos_ekspertnoe_obsuzhdenie_problem_tsifrovizatsii_zdravookhraneni/.The Public Chamber of the Russian Federation hosted an expert discussion of the problems of digitalization of healthcare. (In Rus.) Режим доступа: https://bm24.ru/obshchestvo/v_obshchestvennoy_palate_rf_sostoyalos_ekspertnoe_obsuzhdenie_problem_tsifrovizatsii_zdravookhraneni/.VI конференция «Цифровая индустрия промышленной России». Режим доступа: https://clinical-pharmacy.ru/allnews/8717-vi-konferenciyacifrovaya-industriya-promyshlennoy-rossii.html.VI Conference "Digital Industry of Industrial Russia". (In Rus.) Режим доступа: https://clinical-pharmacy.ru/allnews/ 717-vi-konferenciya-cifrovaya-industriya-promyshlennoy-rossii.html.16 сентября состоялась II Ежегодная научно-практическая конференция с международным участием «RWD/RWE — инструменты исследования реальной клинической практики: сегодня и завтра». Режим доступа: https://aston-health.com/about-us/press-center/news/16-sentyabrya-sostoyalas-ii-ezhegodnayanauchno-prakticheskaya-konferencziya-smezhdunarodnyim-uchastiem-%C2%ABrwd/rwe-instrumentyi-issledovaniya-realnojklinicheskoj-praktiki-segodnya-i-zavtra%C2%BB/.On September 16 took place the II Annual scientific and practical conference with international participation "RWD/RWE – research tools for real clinical practice: today and tomorrow". (In Rus.) Режим доступа: https://aston-health.com/about-us/press-center/news/16-sentyabrya-sostoyalas-ii-ezhegodnaya-nauchno-prakticheskaya-konferencziya-s-mezhdunarodnyim-uchastiem-%C2%ABrwd/rwe-instrumentyi-issledovaniya-realnoj-klinicheskoj-praktiki-segodnya-i-zavtra%C2%BB/.Международный онлайн-семинар «Кокрейновские систематические обзоры: надёжные доказательства для мудрых решений в медицинском образовании, науке и практике», 3 декабря 2021 года, Москва. Режим доступа: https://cochranerussia.cddexpert.com/.International online seminar "Cochrane Systematic Reviews: Reliable Evidence for Wise Decisions in Medical Education, Science and Practice", December 3, 2021, Moscow (In Rus.)

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