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Criteria for the use of omics-based predictors in clinical trials

Author

Listed:
  • Lisa M. McShane

    (National Cancer Institute, National Institutes of Health)

  • Margaret M. Cavenagh

    (National Cancer Institute, National Institutes of Health)

  • Tracy G. Lively

    (National Cancer Institute, National Institutes of Health)

  • David A. Eberhard

    (University of North Carolina)

  • William L. Bigbee

    (Hillman Cancer Center, University of Pittsburgh School of Medicine)

  • P. Mickey Williams

    (Frederick National Laboratory for Cancer Research, National Cancer Institute, National Institutes of Health)

  • Jill P. Mesirov

    (Broad Institute of Massachusetts Institute of Technology and Harvard University)

  • Mei-Yin C. Polley

    (National Cancer Institute, National Institutes of Health)

  • Kelly Y. Kim

    (National Cancer Institute, National Institutes of Health)

  • James V. Tricoli

    (National Cancer Institute, National Institutes of Health)

  • Jeremy M. G. Taylor

    (University of Michigan)

  • Deborah J. Shuman

    (National Cancer Institute, National Institutes of Health)

  • Richard M. Simon

    (National Cancer Institute, National Institutes of Health)

  • James H. Doroshow

    (National Cancer Institute, National Institutes of Health)

  • Barbara A. Conley

    (National Cancer Institute, National Institutes of Health)

Abstract

A checklist of criteria to determine the readiness of high-throughput ‘omics’-based tests for guiding patient therapy in clinical trials is discussed; the checklist, developed by the US National Cancer Institute in collaboration with additional scientists with relevant expertise, provides a framework to evaluate the strength of evidence for a test and outlines practical issues to consider before using the test in a clinical setting, with an aim to avoid premature advancement of omics-based tests in clinical trials.

Suggested Citation

  • Lisa M. McShane & Margaret M. Cavenagh & Tracy G. Lively & David A. Eberhard & William L. Bigbee & P. Mickey Williams & Jill P. Mesirov & Mei-Yin C. Polley & Kelly Y. Kim & James V. Tricoli & Jeremy M, 2013. "Criteria for the use of omics-based predictors in clinical trials," Nature, Nature, vol. 502(7471), pages 317-320, October.
    • Handle: RePEc:nat:nature:v:502:y:2013:i:7471:d:10.1038_nature12564
    DOI: 10.1038/nature12564
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