Real-world data: principles of use in decision making and in health technology assessment

Author:

Omelyanovskiy V. V.1ORCID,Gorkavenko F. V.2ORCID,Ignatyeva N. V.3ORCID,Mukhortova P. A.4ORCID,Ryzhova O. R.4ORCID,Teptsova T. S.2ORCID,Kingshott A. A.2ORCID,Kondratyeva B. B.4ORCID

Affiliation:

1. Center for Healthcare Quality Assessment and Control; Financial Research Institute; Russian Medical Academy of Continuing Professional Education; Semashko National Research Institute of Public Health

2. Center for Healthcare Quality Assessment and Control; Russian Medical Academy of Continuing Professional Education

3. Sechenov University

4. Center for Healthcare Quality Assessment and Control

Abstract

The use of real-world data (RWD) and real-world evidence (RWE) in process of improving public health, their assessment, and use in decision making is a promising area. Discussions are actively underway about the possibility of using RWD and RWE in routine medical practice of doctors and health care organizers, the weaknesses of these matters and ways to overcome them. Taking into account the considerable amount of information, complexity, and inconsistency of issues under consideration, the article presents the basic principles of using RWD and RWE in decision making, classification of health technologies values, classification of RWE sources, position of RWD studies in the hierarchy of clinical study designs, as well as the ways of their use in complex drug assessment.

Publisher

IRBIS

Subject

Public Health, Environmental and Occupational Health,Health Policy,Pharmacology

Reference21 articles.

1. Mukhortova P.A., Gorkavenko P.V., Strunina Yu.V., Omelyanovskiy V.V., Kalinichenko V.V. Use of real-world data for decision making in Canada and United Kingdom. Real-World Data & Evidence. 2022: 2 (3): 7–19 (in Russ.). https://doi.org/10.37489/2782-3784-myrwd-18.

2. Lin L.W., Ahn J., Bayani D.B.S., et al. Use of real-world data and real-world evidence to support drug reimbursement decision-making in Asia. Available at: https://hiper.nus.edu.sg/wp-content/uploads/2021/05/REALISE-Abridged-guidance-for-users-of-HTA_20201104-version-1.0-2.pdf (in Russ.) (accessed 03.03.2023).

3. Borzova M.A. Real-world data: general regulatory approaches in the EU and Japan. Real-World Data & Evidence. 2022: 2 (1): 11–6 (in Russ.). https://doi.org/10.37489/2782-3784-myrwd-7.

4. NICE real-world evidence framework. Available at: https://www.nice.org.uk/corporate/ecd9/resources/nice-realworld-evidence-framework-pdf-1124020816837 (in Russ.) (accessed 03.03.2023).

5. Framework for FDA’s real-world evidence program. Available at: https://www.fda.gov/media/120060/download (in Russ.) (accessed 03.03.2023).

Cited by 1 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3