Should the two‐trial paradigm still be the gold standard in drug assessment?

Two significant pivotal trials are usually required for a new drug approval by a regulatory agency. This standard requirement is known as the two‐trial paradigm. However, several authors have questioned why we need exactly two pivotal trials, what statistical error the regulators are trying to prote...

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Veröffentlicht in:	Pharmaceutical statistics : the journal of the pharmaceutical industry 2023-01, Vol.22 (1), p.96-111
Hauptverfasser:	Zhan, Stella Jinran, Kunz, Cornelia Ursula, Stallard, Nigel
Format:	Artikel
Sprache:	eng
Schlagworte:	Clinical trials Main Paper Main Papers Pharmaceutical industry Pharmaceuticals pivotal trials pooled analysis power regulatory guideline type I error control
Online-Zugang:	Volltext
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