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 (HTA) 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.
