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Author

Jean-Christophe Lega

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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
Review Open access Sep 2026

From Inference to Ritual: Why Frequentist Statistics Became Hard to Understand and Teach in Medicine

ABSTRACT Introduction Frequentist statistical tools still structure a large part of biomedical research, regulatory evaluation, and medical teaching, even though their correct interpretation remains uncertain among students, clinicians, and readers of the literature. This misunderstanding is usually attributed to pedag...

Jean-Christophe Lega, Sylvie Chevret · 0 citations

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