Predictive biomarker validation in practice: lessons from real trials.

  title={Predictive biomarker validation in practice: lessons from real trials.},
  author={Sumithra J. Mandrekar and Daniel J. Sargent},
  journal={Clinical trials},
  volume={7 5},
BACKGROUND With the advent of targeted therapies, biomarkers provide a promising means of individualizing therapy through an integrated approach to prediction using the genetic makeup of the disease and the genotype of the patient. Biomarker validation has therefore become a central topic of discussion in the field of medicine, primarily due to the changing landscape of therapies for treatment of a disease and these therapies purported mechanism(s) of action. PURPOSE In this report, we… CONTINUE READING
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