References

farmaec

FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

ФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология

2070-49092070-4933

IRBIS LLC

10.17749/2070-4909/farmakoekonomika.2022.120

farmaec-715

Research Article

REVIEW ARTICLES

ОБЗОРНЫЕ ПУБЛИКАЦИИ

The role of real world data and real world evidence in health technology assessment

Значение исследований реальной клинической практики в оценке технологий здравоохранения

https://orcid.org/0000-0002-7657-5973

Новодережкина

Е. А.

Novoderezhkina

E. A.

Новодережкина Евгения Алексеевна – соискатель ученой степени кандидата наук, кафедра общей и клинической фармакологии.

Ул. Миклухо-Маклая, д. 10, корп. 3, Москва 117198

Evgeniya А. Novoderezhkina – PhD Applicant, Chair of General and Clinical Pharmacology.

10 corp. 3 Miklukho-Maklay Str., Moscow 117198

evgeniyanovoderezhkina@gmail.com

https://orcid.org/0000-0002-6348-6867

Зырянов

С. К.

Zyryanov

S. К.

Зырянов Сергей Кенсаринович – доктор медицинских наук, профессор, заведующий кафедрой общей и клинической фармакологии; WoS ResearcherID: D-8826-2012; Scopus Author ID: 35796816700; РИНЦ SPIN-код: 2725-9981.

Ул. Миклухо-Маклая, д. 10, корп. 3, Москва 117198

Sergey К. Zyryanov – Dr. Med. Sc., Professor, Chief of Chair of General and Clinical Pharmacology; WoS ResearcherID: D-8826-2012; Scopus Author ID: 35796816700; RSCI SPIN-code: 2725-9981.

10 corp. 3 Miklukho-Maklay Str., Moscow 117198

Федеральное государственное автономное образовательное учреждение высшего образования «Российский университет дружбы народов»РоссияPeoples’ Friendship University of RussiaRussian Federation

2022

09102022

153380389

2022

Новодережкина Е.А., Зырянов С.К.

Novoderezhkina E.A., Zyryanov S.К.

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

https://www.pharmacoeconomics.ru/jour/article/view/715

Real world data (RWD) and real world evidence (RWE) is one of the most rapidly developing areas in the modern health care systems, which is caused by the development of technologies for both collecting and analyzing data, the emergence of new data sources and the formation of needs both by regulatory bodies, health technology assessment (HTA) agencies, and by the clinical and scientific communities. However, at the moment, there is no universal approach to RWD/E generation and application in the context of HTA. Over the past few years, the rate of including RWD/E in the HTA dossier has noticeably increased, but the nature of the existing guidelines and recommendations is rather fragmentary, which might create obstacles in the way of RWD/E study development and submission. The publication is aimed to describe and summarize the main and most rapidly developing spheres of RWD/E applications and analyze the possibilities of using RWD/E in various HTA areas in the world and in the Russian Federation considering the main trends in the further HTA development.

В современном мире область данных, собираемых в условиях реальной клинической практики (РКП; англ. real world data, RWD), а также доказательств, получаемых путем анализа данных РКП (англ. real world evidence, RWE), является одной из наиболее быстро развивающихся направлений в системе здравоохранения, что вызвано развитием технологий сбора и анализа информации, появлением новых источников данных, а также формированием потребности со стороны как регуляторных органов, агентств по оценке технологий здравоохранения (ОТЗ), так и клинического и научного сообществ. Однако в настоящий момент не существует универсального подхода к генерации и применению данных и доказательств РКП в контексте ОТЗ. Несмотря на наблюдающееся в последние несколько лет увеличение частоты включения данных РКП в досье для ОТЗ, природа существующих руководств и рекомендаций достаточно фрагментарна, что осложняет процесс разработки исследований РКП. Целью данного обзора является описание и суммирование основных и наиболее быстро развивающихся сфер использования данных и доказательств РКП, а также анализ возможностей применения данных РКП в различных областях ОТЗ в мире и Российской Федерации с учетом основных тенденций развития ОТЗ.

оценка технологий здравоохраненияОТЗреальная клиническая практикаРКПдоказательства в условиях реальной клинической практикифармакоэкономический анализисследование экономики и результатов здравоохранения

Health technology assessmentHTAreal world dataRWDreal world evidenceRWEpharmacoeconomic analysishealth economics and outcomes researchHEOR

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