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

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. G. Taylor, Deborah J. Shuman, Richard M. Simon, James H. Doroshow and Barbara A. Conley
Additional contact information
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

Nature, 2013, vol. 502, issue 7471, 317-320

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.

Date: 2013
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DOI: 10.1038/nature12564

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