Biomarker based clinical trial design.

  title={Biomarker based clinical trial design.},
  author={R. Simon},
  journal={Chinese clinical oncology},
  volume={3 3},
The established molecular heterogeneity of human cancers and the subsequent stratification of conventional diagnostic categories require the development of new paradigms for the development of a reliable basis for predictive medicine. We review clinical trial designs for the development of new therapeutics and predictive biomarkers to inform their use. We cover designs for a wide range of settings. At one extreme is the development of a new drug with a single biomarker and strong biological… CONTINUE READING

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Genomic clinical trials and predictive medicine

  • RM Simon
  • 2013
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