title: Criteria for the use of omics-based predictors in clinical trials.
abstract: 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.
authors.affiliation: Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892, USA. mcshanel@ctep.nci.nih.gov
authors.forename: Lisa M
authors.initials: LM
authors.lastname: McShane
authors.forename: Margaret M
authors.initials: MM
authors.lastname: Cavenagh
authors.forename: Tracy G
authors.initials: TG
authors.lastname: Lively
authors.forename: David A
authors.initials: DA
authors.lastname: Eberhard
authors.forename: William L
authors.initials: WL
authors.lastname: Bigbee
authors.forename: P Mickey
authors.initials: PM
authors.lastname: Williams
authors.forename: Jill P
authors.initials: JP
authors.lastname: Mesirov
authors.forename: Mei-Yin C
authors.initials: MY
authors.lastname: Polley
authors.forename: Kelly Y
authors.initials: KY
authors.lastname: Kim
authors.forename: James V
authors.initials: JV
authors.lastname: Tricoli
authors.forename: Jeremy M G
authors.initials: JM
authors.lastname: Taylor
authors.forename: Deborah J
authors.initials: DJ
authors.lastname: Shuman
authors.forename: Richard M
authors.initials: RM
authors.lastname: Simon
authors.forename: James H
authors.initials: JH
authors.lastname: Doroshow
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Conley
mesh_terms: D057189:Checklist; D002986:Clinical Trials as Topic / Q000191:economics / Q000941:ethics / Q000379:methods* / Q000592:standards; D005069:Evaluation Studies as Topic; D023281:Genomics / Q000941:ethics; D006801:Humans; D008954:Models, Biological; D054547:National Cancer Institute (U.S.) / Q000191:economics; D057285:Precision Medicine / Q000941:ethics / Q000379:methods / Q000592:standards; D012107:Research Design / Q000592:standards; D013048:Specimen Handling; D014481:United States