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Nature DOI:10.1038/nature12564

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

Publication TypeJournal Article
Year of Publication2013
AuthorsMcShane, LM, Cavenagh, MM, Lively, TG, Eberhard, DA, Bigbee, WL, P Williams, M, Mesirov, JP, Polley, M-YC, Kim, KY, Tricoli, JV, Taylor, JMG, Shuman, DJ, Simon, RM, Doroshow, JH, Conley, BA
Date Published2013 Oct 17
KeywordsChecklist, Clinical Trials as Topic, Evaluation Studies as Topic, Genomics, Humans, Models, Biological, National Cancer Institute (U.S.), Precision Medicine, Research Design, Specimen Handling, United States

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.


Alternate JournalNature
PubMed ID24132288
PubMed Central IDPMC4180668
Grant ListP30 CA046592 / CA / NCI NIH HHS / United States
R01 CA129102 / CA / NCI NIH HHS / United States
Z99 CA999999 / / Intramural NIH HHS / United States