Determining the non-inferiority margin for patient reported outcomes

One of the cornerstones of any non‐inferiority trial is the choice of the non‐inferiority margin delta. This threshold of clinical relevance is very difficult to determine, and in practice, delta is often “negotiated” between the sponsor of the trial and the regulatory agencies. However, for patient...

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Veröffentlicht in:Pharmaceutical statistics : the journal of the pharmaceutical industry 2011-09, Vol.10 (5), p.410-413
Hauptverfasser: Gerlinger, Christoph, Schmelter, Thomas
Format: Artikel
Sprache:eng
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