Assessing Clinical Equivalence in Oncology Biosimilar Trials With Time-to-Event Outcomes

A typical biosimilar study in oncology uses the overall response evaluated at a specific time point as the primary endpoint, which is generally acceptable regulatorily, to assess clinical equivalence between a biosimilar and its reference product. The standard primary endpoint for evaluating an anti...

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Veröffentlicht in:	JNCI cancer spectrum 2019-12, Vol.3 (4), p.pkz058-pkz058
Hauptverfasser:	Uno, Hajime, Schrag, Deborah, Kim, Dae Hyun, Tang, Dejun, Tian, Lu, Rugo, Hope S, Wei, Lee-Jen
Format:	Artikel
Sprache:	eng
Schlagworte:	Analysis Antineoplastic agents Backup software Cancer treatment Clinical trials Oncology Time
Online-Zugang:	Volltext
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