Problems of real-world evidence studies: qualitative survey of industry representatives

Objective. To identify strengths and weaknesses of weal-world evidence (RWE) studies in Russia, needs and proposals in this area. Material and methods. The study used the method of semi-structured in-depth interviews with experts in RWE: 10 pharmaceutical companies, 6 contract research organizations and 3 providers of study infrastructure. There were 19 expert interviews between September 23, 2025 and November 14, 2025. Each one included 23 questions combined into 4 blocks: 1) description of respondents, 2) problems in RWE studies, 3) ensuring the quality of RWE studies, 4) regulatory needs. Results. Analysis of responses revealed 9 main categories reflecting the key barriers for RWE studies. All respondents noted barriers in such areas as regulatory and legislative aspects, study planning; 94.7% of experts — interaction between RWE study sites, competencies and expertise, data quality; 89.5% of respondents — agreement and coordination, 73.7% — budget and financing, 52.6% — standardization, 10.5% — technical and infrastructure constraints. All three groups of respondents unanimously identified the following critical problems: RWD quality, regulatory uncertainty (lack of significant regulations for decision-making), lack of competences, and significant underestimation of RWE study complexity. Conclusion. Only institutionalized quality management at all levels of study, supported by regulatory framework, centralization of data and certification of market participants can ensure that RWE studies are recognized by the state as an equal source of evidence for medical, regulatory, and economic decision-making.