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Author

Sylvie Chevret

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
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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