期刊
JOURNAL OF THORACIC ONCOLOGY
卷 6, 期 4, 页码 658-660出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/JTO.0b013e31820e17cb
关键词
All-comers; Adaptive; Biomarker; Enrichment; Phase II; Randomized
资金
- National Cancer Institute, Mayo Clinic Cancer Center [CA-15083]
- National Cancer Institute, North Central Cancer Treatment Group [CA-25224]
Designs 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. The strength of the preliminary evidence, the prevalence of the marker, the reproducibility and validity of the assay, and the feasibility of real-time marker assessment play a major role in the choice of the design. In this report, we discuss the parameters under which the enrichment or an all-comers design strategy would be appropriate for phase II trials.
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