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- W2569062786 abstract "Abstract Developments in genomics provide a biological understanding for the heterogeneity of clinical course and response to treatment that have long been observed. The ability to molecularly characterize human diseases presents new opportunities to develop more effective treatments and new challenges for the design and analysis of clinical trials. The established molecular heterogeneity of human diseases requires the development of new paradigms for the design and analysis of randomized clinical trials as a reliable basis for precision medicine. In this chapter we review prospective designs for the development of new therapeutics and predictive biomarkers to inform their use. The designs reviewed include the new phase II “basket” designs in which drugs are matched to patients based on the somatic mutations found, regardless of the histologic type of the cancer. We will discuss phase III enrichment designs which have been used for numerous successful pivotal clinical trials by the pharmaceutical industry and the “umbrella” designs which represent multiple enrichment designs linked by a common infrastructure for tumor characterization. Finally we will describe the adaptive enrichment designs for settings where the appropriate predictive biomarker is not clearly identified by the start of the phase III clinical trial of the test drug to be evaluated." @default.
- W2569062786 created "2017-01-13" @default.
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- W2569062786 date "2017-01-01" @default.
- W2569062786 modified "2023-09-28" @default.
- W2569062786 title "Clinical Trials in Precision Medicine" @default.
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- W2569062786 doi "https://doi.org/10.1016/b978-0-12-809411-2.00011-8" @default.
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