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, Barbara A. Conley

Research output: Contribution to journalReview articlepeer-review

146 Scopus citations


The US National Cancer Institute (NCI), in collaboration with scientists representing multiple areas of expertise relevant to 'omics'-based test development, has developed a checklist of criteria that can be used to determine the readiness of omics-based tests for guiding patient care in clinical trials. The checklist criteria cover issues relating to specimens, assays, mathematical modelling, clinical trial design, and ethical, legal and regulatory aspects. Funding bodies and journals are encouraged to consider the checklist, which they may find useful for assessing study quality and evidence strength. The checklist will be used to evaluate proposals for NCI-sponsored clinical trials in which omics tests will be used to guide therapy.

Original languageEnglish (US)
Pages (from-to)317-320
Number of pages4
Issue number7471
StatePublished - 2013

ASJC Scopus subject areas

  • General


Dive into the research topics of 'Criteria for the use of omics-based predictors in clinical trials'. Together they form a unique fingerprint.

Cite this