@article{8934b90bce814081b7f0b2caefd2ccc9,
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.",
author = "McShane, {Lisa M.} and Cavenagh, {Margaret M.} and Lively, {Tracy G.} and Eberhard, {David A.} and Bigbee, {William L.} and Williams, {P. Mickey} and Mesirov, {Jill P.} and Polley, {Mei Yin C.} and Kim, {Kelly Y.} and Tricoli, {James V.} and Taylor, {Jeremy M.G.} and Shuman, {Deborah J.} and Simon, {Richard M.} and Doroshow, {James H.} and Conley, {Barbara A.}",
note = "Funding Information: 1Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892, USA. 2Department of Pathology and Lineberger Comprehensive Cancer Center,UniversityofNorthCarolina,ChapelHill,NorthCarolina27599,USA.3DepartmentofPathologyandUniversityofPittsburghCancerInstitute,HillmanCancerCenter,UniversityofPittsburghSchool of Medicine, Pittsburgh, Pennsylvania 15213, USA. 4Frederick National Laboratory for Cancer Research, National Cancer Institute, National Institutes of Health, Frederick, Maryland 21702, USA. 5Broad Institute of Massachusetts Institute of Technology and Harvard University, Cambridge, Massachusetts 02142, USA. 6Department of Biostatistics, University of Michigan, Ann Arbor, Michigan 48109, USA.",
year = "2013",
doi = "10.1038/nature12564",
language = "English (US)",
volume = "502",
pages = "317--320",
journal = "Nature",
issn = "0028-0836",
publisher = "Nature Publishing Group",
number = "7471",
}