Purpose: Pharmaceutical claims are often accurate at the level of the clinical trial endpoint yet are read by consumers as promises about living longer or feeling better. This paper theorises that translation problem and develops a regulatory-marketing framework linking evidence properties, claim design and consumer inference.
Design/methodology/approach: The paper is conceptual. It integrates four literature streams, covering surrogate endpoint validity and expedited approval, pharmaceutical promotion and consumer comprehension, marketing theory on information asymmetry, signalling, inference and disclosure, and international regulatory guidance. Synthesis is concept-centric and yields construct definitions, a framework and propositions rather than pooled evidence.
Findings: The framework introduces evidentiary distance, the separation between the clinical meaning an endpoint supports and the patient benefit a recipient can reasonably infer from a communication built on it. It is a property of the evidence-claim pair, not of the evidence alone. Six propositions link it to claim amplification, transparency calibration, consumer benefit inference and trust, moderated by framing, disclosure comprehensibility, literacy and disease severity.
Practical implications: Marketers and medical-legal-regulatory reviewers can assess evidentiary distance alongside literal claim accuracy, testing whether inferred benefit stays within the scope the endpoint supports. Regulators can judge disclosures by whether they correct inference rather than merely state facts.
Originality/value:The phenomenon has been observed in regulatory science and health communication but has not been given a marketing-theoretic account. The paper supplies that account, defines four constructs and sets out a measurement agenda.