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.
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