Randomized, Controlled, and Real.

Area of Science:

• Clinical research methodology
• Epidemiological study design

Background:

• The term 'real-world evidence' (RWE) categorizes research by practice proximity, not methodology.
• RWE is often derived from routine clinical data, implying greater 'real-life' relevance than randomized controlled trials (RCTs).

Purpose of the Study:

• To critique the conceptual distinction between RWE and RCTs.
• To argue that methodological structures, not perceived 'realness,' differentiate study types.
• To clarify the concepts of external validity, representativeness, and generalizability in clinical research.

Main Methods:

• Conceptual analysis of research terminology and classification.
• Examination of methodological trade-offs in epidemiological study designs.
• Critique of the 'real-world evidence' versus 'randomized controlled trial' dichotomy.

Main Results:

• The distinction between RWE and RCTs is conceptually misleading; both are empirical.
• Methodological structures, such as randomization, reduce error to isolate causal effects.
• Representativeness does not equate to scientific validity; contextual applicability is key for inference.

Conclusions:

• Randomized trials, observational studies, and quasi-experimental designs differ in methodological dimensions, not epistemic categories.
• RWE and RCTs should be evaluated based on explicit methodological principles, not rhetorical labels.
• Abandoning terms like RWE may foster greater conceptual clarity in evaluating clinical evidence.