Design of clinical trials for biomarker research in oncology.

  title={Design of clinical trials for biomarker research in oncology.},
  author={Sumithra J. Mandrekar and Daniel J. Sargent},
  journal={Clinical investigation},
  volume={1 12},
The developmental pathway from discovery to clinical practice for biomarkers and biomarker-directed therapies is complex. While several issues need careful consideration, two critical issues that surround the validation of biomarkers are the choice of clinical trial design (which is based on the strength of the preliminary evidence and marker prevalence) and the biomarker assay related issues surrounding the marker assessment methods such as the reliability and reproducibility of the assay… CONTINUE READING

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