References

farmaec

FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

ФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология

2070-49092070-4933

IRBIS LLC

10.17749/2070-4909/farmakoekonomika.2023.199

farmaec-952

Research Article

REVIEW ARTICLES

ОБЗОРНЫЕ ПУБЛИКАЦИИ

Peculiarities of real-world data application for health technology assessment in Asian countries

Особенности применения данных реальной клинической практики при проведении оценки медицинских технологий в странах Азии

https://orcid.org/0000-0001-5538-6965

Кондратьева

Б. Б.

Kondratyeva

B. B.

Кондратьева Бэла Батразовна – ведущий специалист отдела методологического обеспечения проведения комплексной оценки технологий в здравоохранении

Хохловский пер., д. 10/5, Москва 109028, Россия

Bela B. Kondratyeva – Leading Expert, Department of Methodological Support for Comprehensive Assessment of Technologies in Healthcare

10/5 Khokhlovskiy Passage, Moscow 109028, Russia

kondrateva@rosmedex.ru

https://orcid.org/0000-0002-4586-2451

Горкавенко

Ф. В.

Gorkavenko

F. V.

Горкавенко Филипп Васильевич – заместитель начальника отдела методологического обеспечения проведения комплексной оценки технологийв здравоохранении; ассистент кафедры организации здравоохранения и общественного здоровья с курсом оценки технологий здравоохранения; соискатель кафедры фармакологии Института фармации им. А.П. Нелюбина

Хохловский пер., д. 10/5, Москва 109028, Россия

ул. Баррикадная, д. 2, стр. 1, Москва 123995, Россия

ул. Трубецкая, д. 8, стр. 2, Москва 119991, Россия

Filipp V. Gorkavenko – Deputy Head of Department of Methodological Support for Comprehensive Assessment of Technologies in Healthcare; Assistant Professor, Chief of Chair of Healthcare Organization and Public Health with a Course in Health Technology Assessment; Applicant, Chair of Pharmacology, Nelyubin Institute of Pharmacy

10/5 Khokhlovskiy Passage, Moscow 109028, Russia

2/1 bldg 1 Barrikadnaya Str., Moscow 123242, Russia

8 bldg 2 Trubetskaya Str., Moscow 119991, Russia

https://orcid.org/0000-0003-1581-0703

Омельяновский

В. В.

Omelyanovskiy

V. V.

Омельяновский Виталий Владимирович – д.м.н., профессор, генеральный директор; заведующий кафедрой организации здравоохранения и общественного здоровья с курсом оценки технологий здравоохранения; руководитель Центра финансов здравоохранения; главный научный сотрудник отдела экономических исследований в здравоохранении

WoS ResearcherID: P-6911-2018; Scopus Author ID: 6507287753

Хохловский пер., д. 10/5, Москва 109028, Россия

ул. Баррикадная, д. 2, стр. 1, Москва 123995, Россия

Настасьинский пер., д. 3, стр. 2, Москва 127006, Россия

ул. Воронцово поле, д. 12, стр. 1, Москва 105064, Россия

Vitaliy V. Omelyanovskiy – Dr. Med. Sc., Professor, Director General; Chief of Chair of Healthcare Organization and Public Health with a Course in Health Technology Assessment; Head of Center for Healthcare Finance; Chief Researcher, Department of Economic Research in Healthcare

WoS ResearcherID: P-6911-2018; Scopus Author ID: 6507287753

10/5 Khokhlovskiy Passage, Moscow 109028, Russia

2/1 bldg 1 Barrikadnaya Str., Moscow 123242, Russia

3/2 Nastasyinskiy Passage, Moscow 127006, Russia

12 bldg 1 Vorontsovo Pole Str., Moscow 105064, Russia

Федеральное государственное бюджетное учреждение «Центр экспертизы и контроля качества медицинской помощи» Министерства здравоохранения Российской ФедерацииРоссияCenter for Healthcare Quality Assessment and ControlRussian Federation

Федеральное государственное бюджетное учреждение «Центр экспертизы и контроля качества медицинской помощи» Министерства здравоохранения Российской Федерации; Федеральное государственное бюджетное образовательное учреждение дополнительного профессионального образования «Российская медицинская академия непрерывного профессионального образования»; Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет им. И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)РоссияCenter for Healthcare Quality Assessment and Control; Russian Medical Academy of Continuing Professional Education; Sechenov UniversityRussian Federation

Федеральное государственное бюджетное учреждение «Центр экспертизы и контроля качества медицинской помощи» Министерства здравоохранения Российской Федерации; Федеральное государственное бюджетное образовательное учреждение дополнительного профессионального образования «Российская медицинская академия непрерывного профессионального образования»; Федеральное государственное бюджетное учреждение «Научно-исследовательский финансовый институт» Министерства финансов Российской Федерации; Федеральное государственное бюджетное научное учреждение «Национальный научно-исследовательский институт общественного здоровья им. Н.А. Семашко»РоссияCenter for Healthcare Quality Assessment and Control; Russian Medical Academy of Continuing Professional Education; Financial Research Institute; Semashko National Research Institute of Public HealthRussian Federation

2023

30122023

164671680

2024

Кондратьева Б.Б., Горкавенко Ф.В., Омельяновский В.В.

Kondratyeva B.B., Gorkavenko F.V., Omelyanovskiy V.V.

This work is licensed under a Creative Commons Attribution 4.0 License.

https://www.pharmacoeconomics.ru/jour/article/view/952

The article is devoted to the study of regulatory approaches to the sphere of real-world data (RWD) and real world evidence (RWE) in the countries of the Asia-Pacific Region (China, South Korea, Japan, Taiwan, etc.) and examples of their practical application for health technology assessment. The peculiarities of collecting and gaining access to RWD/RWE in Asian countries, prerequisites for the development of this direction, adopted regulations, developed methodological guidelines, promising areas of application, and clinical and economic research based on country-specific data are considered. The existing practices in Asian countries represent valuable experience, some of which could be considered for implementation in the national practice.

Статья посвящена изучению подходов к нормативному регулированию в сфере данных реальной клинической практики (РКП) в странах Азиатско-Тихоокеанского региона (Китай, Южная Корея, Япония, Тайвань и др.) и примеров их практического применения для оценки технологий здравоохранения. Рассмотрены особенности сбора и получения доступа к данным РКП в странах Азии, предпосылки развития этого направления, принятые нормативные правовые акты, разработанные методические руководства, перспективные области применения и клинико-экономические исследования, опирающиеся на страноспецифические данные. Существующие в странах Азии наработки представляют собой ценный опыт, часть которого можно рассмотреть для внедрения в отечественной практике.

Реальная клиническая практикаРКПрутинная клиническая практикаоценка технологий здравоохранениянормативное регулированиемеждународный опыт

Real-world dataRWDreal-world evidenceRWEroutine clinical practicehealth technology assessmentregulationinternational experience

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