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- W2490545138 abstract "Many standard diagnostic categories are heterogeneous in molecular pathogenesis and treatment responsiveness. This inhibits the development of new treatments, requiring large clinical trials to identify small average treatment benefits for heterogeneous groups of patients. In oncology, genomic technologies provide powerful tools for identification of patients who require systemic treatment and for selecting the most appropriate drug. Development of drugs with companion diagnostics offers the potential of improving treatment decisions for individual patients, containing healthcare costs by limiting over-treatment of patients with drugs from which they do not benefit, and increasing the success rate of new drug development. However, development of drugs with companion diagnostics increases the complexity of clinical development and requires new approaches to the design and analysis of clinical trials. Adapting to the fundamental importance of tumor genomics will require paradigm changes by clinical and statistical investigators in academia, industry and government. In this chapter we discuss the design of clinical trials for evaluating the medical utility of prognostic and predictive biomarkers." @default.
- W2490545138 created "2016-08-23" @default.
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- W2490545138 date "2013-01-01" @default.
- W2490545138 modified "2023-10-05" @default.
- W2490545138 title "Designing Genomics-Based Clinical Studies" @default.
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- W2490545138 doi "https://doi.org/10.1016/b978-0-12-382227-7.00020-3" @default.
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