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All-Comers versus Enrichment Design Strategy in Phase II Trials

Designs for biomarker validation have been proposed and utilized in the Phase III oncology clinical trial setting. Broadly speaking, these designs follow either an enrichment (i.e., targeted) strategy or an all-comers (i.e., unselected) strategy. An enrichment design screens patients for the presenc...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: Mandrekar, Sumithra J., Sargent, Daniel J.
Format: Artigo
Sprache:Inglês
Veröffentlicht: 2011
Schlagworte:
Online Zugang:https://ncbi.nlm.nih.gov/pmc/articles/PMC3082391/
https://ncbi.nlm.nih.gov/pubmed/21532916
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1097/JTO.0b013e31820e17cb
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