The epistemological trap from the real-world evidence concept

Area of Science:

• Epistemology of scientific research
• Methodology in health sciences
• Philosophy of science

Background:

• The term 'real-world' evidence (RWE) is increasingly used for data outside randomized controlled trials (RCTs).
• RWE lacks a standardized definition and a solid epistemological basis.
• Current terminology implies RWE captures objective truth better than controlled experiments, undermining transparency.

Purpose of the Study:

• To critically analyze the epistemological foundation of 'real-world' evidence.
• To explore the 'illusion of the real' in scientific data collection.
• To advocate for transparent scientific terminology.

Main Methods:

• Commentary based on critical epistemological analysis.
• Examination of the philosophical underpinnings of RWE.
• Analysis of data collection as an active, interventionist process.

Main Results:

• RWE collection is an active intervention, not a neutral process, introducing structural biases.
• Neither RCTs nor observational studies can access absolute truth due to the observer effect.
• The pursuit of 'real' evidence leads to contextual constructions rather than objective truths.

Conclusions:

• The 'real-world' label is a rhetorical construct obscuring study design and creating an illusion of objectivity.
• All scientific inquiry is limited by methodology; 'real-world' claims are fallacious.
• Abandoning RWE terminology for precise study labels and disclosing data limitations promotes transparency.