The epistemological trap from the real-world evidence concept

OBJECTIVES: 'Real-world' evidence (RWE) and related terms are gaining popularity in the scientific literature, usually in reference to evidence collected outside of traditional randomized controlled trials (RCTs). However, the concept lacks a standardized definition and rests on a poor epistemological foundation. This commentary explores the 'illusion of the real,' arguing that RWE-related terminology undermines scientific transparency by implying that routinely collected data capture an objective truth more effectively than controlled experiments. METHODS: A commentary with critical epistemological analysis of RWE. RESULTS: RWE underpins the epistemological illusion that the collection of observational or routine data is a passive, neutral, or intervention-free process. In fact, collecting data is, in itself, an active intervention by the researcher: an intervention that modifies, filters, and constructs the observed reality. This intervention introduces structural biases that remove any evidence of the supposed 'real truth.' Neither RCTs nor observational studies can perhaps access the absolute truth, since the act of observing and control already alters the phenomenon. The pursuit of 'real' evidence creates an anarchic methodological space where the lack of control is mistaken for authenticity, ultimately producing contextual constructions rather than objective truths. CONCLUSION: Although data collected outside traditional RCTs are essential to decision-making, the 'real-world' label is a rhetorical construct that obscures study design and introduces an illusion of objective truth. Because all scientific inquiries are limited by the observer's methods, 'real-world' claims are essentially fallacious. To promote transparency, researchers should abandon RWE-related terminology in favor of precise study labeling and explicit disclosures of data source limitations.