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New designs for basket clinical trials in oncology

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ABSTRACT The established molecular heterogeneity of human cancers has had profound effects on the design of cancer therapeutics. Most cancer drugs are today targeted to molecular alterations present in cancer… Click to show full abstract

ABSTRACT The established molecular heterogeneity of human cancers has had profound effects on the design of cancer therapeutics. Most cancer drugs are today targeted to molecular alterations present in cancer cells. Tumors of the same primary site, however, often differ with regard to the alterations that they harbor. Consequently, this heterogeneity has required the development of new paradigms for clinical development. In this paper, we review some clinical trial designs finding active use in co-development of therapeutics and predictive biomarkers to inform their use in oncology.

Keywords: designs basket; basket clinical; trials oncology; clinical trials; new designs; oncology

Journal Title: Journal of Biopharmaceutical Statistics
Year Published: 2018

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