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The Erosion of Proof in Paradigm Transitions: The Rise of Narrative Rationality in Health Technology Assessment
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DOI：10.1016/j.jclinepi.2026.112458.png)
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Abstract
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1. Key findings. • This article describes three partly coexisting evidentiary configurations in health technology assessment: the two-trial paradigm, the one-trial paradigm, and the narrative regime. These models differ in how they manage replication, uncertainty, and evidentiary sufficiency. • Contemporary health technology assessment increasingly relies on coherence-based inference rather than independent empirical replication. This evolution may accelerate access to therapies but also increases inferential uncertainty and false-positive risk. 2. What this adds to what is known?. • The article integrates accelerated approvals, intermediate endpoints, real-world evidence, and indirect comparisons within a unified epistemological framework. It links these developments to a broader shift from falsification toward coherence-based reasoning. • It also highlights that regulatory agencies, health technology assessment bodies, and guideline organizations may operate according to partly distinct evidentiary standards. This coexistence helps explain current tensions regarding proof and uncertainty in biomedical evaluation. 3. What is the implication, what should change now?. • Evidentiary flexibility should remain accompanied by safeguards preserving falsifiability, comparative evaluation, and analytical transparency, particularly for non-randomized evidence and weakly anchored comparisons. • Contemporary health technology assessment frameworks may require more explicit management of evidentiary uncertainty, particularly when decisions rely on intermediate endpoints, external controls, or coherence-based inference rather than replicated randomized evidence.
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