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Statistics in Oncology Series
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- Biostatistics For CliniciansOpen Archive
All-Comers versus Enrichment Design Strategy in Phase II Trials
Journal of Thoracic OncologyVol. 6Issue 4p658–660Published in issue: April, 2011- Sumithra J. Mandrekar
- Daniel J. Sargent
Cited in Scopus: 20Designs for biomarker validation have been proposed and used in the phase III oncology clinical trial setting. Broadly, 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 presence or absence of a marker or a panel of markers and then only includes patients who either have or do not have a certain marker characteristic or profile. In contrast, all patients meeting the eligibility criteria (regardless of a particular biomarker status) are entered into an all-comers design.
