Using real-world evidence in healthcare from Western to Central and Eastern Europe: a review of existing barriers

Author:

Kamusheva Maria1ORCID,Németh Bertalan2ORCID,Zemplényi Antal23,Kaló Zoltán24,Elvidge Jamie5,Dimitrova Maria1,Pontén Johan6,Tachkov Konstantin1,Mitkova Zornitsa1

Affiliation:

1. Department of Organization & Economics of Pharmacy, Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria

2. Syreon Research Institute, Budapest, Hungary

3. Division of Pharmacoeconomics, Faculty of Pharmacy, University of Pécs, Pécs, Hungary

4. Centre for Health Technology Assessment, Semmelweis University, Budapest, Hungary

5. Science, Evidence & Analytics Directorate, National Institute for Health & Care Excellence (NICE), Manchester, UK

6. Dental & Pharmaceutical Benefits Agency, Stockholm, Sweden

Abstract

As part of the HTx (Next Generation Health Technology Assessment) project, this study was aimed at identifying the main barriers for application of real-world evidence (RWE) for the purposes of health technology assessment in the Central and Eastern European countries. A mixed methods approach was employed to identify the main barriers: a scoping review of the literature and a series of discussions with stakeholders. Based on the applied approaches, we attempted to summarize the main barriers and challenges related to transferability of RWE in five main groups: technical, regulatory, clinical, scientific and perceptional barriers. Further research should pursue the development of detailed, consensus-based guidelines to improve the harmonization and standardization of RWE.

Funder

European Union’s Horizon 2020 research and innovation programme

Publisher

Becaris Publishing Limited

Subject

Health Policy

Reference36 articles.

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2. Neyt M, Devos C, Thiry N Benefits and costs of innovative oncology drugs in Belgium (2004–2017). Health Technology Assessment (HTA). Belgian Health Care Knowledge Centre (KCE), Brussels, Reports Belgium (2021). https://kce.fgov.be/sites/default/files/atoms/files/KCE_343_Innovative_oncology_drugs_in_Belgium_Report.pdf

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5. USFDA. Use of real-world evidence to support regulatory decision-making for medical devices (2017). www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices

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