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Author

Rémy Boussageon

2 papers indexed here

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Review Open access Aug 2026

Redefining Regulatory Proof: The End of the Two‐Trial Paradigm

The recent decision to establish a single pivotal trial as the default evidentiary standard for Food and Drug Administration (FDA) approval marks a substantive shift in the architecture of regulatory proof. This marks a shift from replication‐based validation to a coherence‐based model of sufficiency, beyond a procedur...

Jean-Christophe Lega, Steeve Provencher, Bruno Falissard et al. · 0 citations
Open access Aug 2026

The Erosion of Proof in Paradigm Transitions: The Rise of Narrative Rationality in Health Technology Assessment.

OBJECTIVE To describe and characterize three partly coexisting evidentiary configurations in drug regulation and health technology assessment (HTA), and to examine the inferential consequences of the progressive shift from replication-based to coherence-oriented standards of proof. STUDY DESIGN AND SETTING Conceptual...

Jean-Christophe Lega, Arthur Gougeon, Claudina Michal et al. · 0 citations

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