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

被引：166

作者：

McShane, Lisa M. ^{[1
]}

Cavenagh, Margaret M. ^{[1
]}

Lively, Tracy G. ^{[1
]}

Eberhard, David A. ^{[2
,3
]}

Bigbee, William L. ^{[4
,5
]}

Williams, P. Mickey ^{[6
]}

Mesirov, Jill P. ^{[7
,8
]}

Polley, Mei-Yin C. ^{[1
]}

Kim, Kelly Y. ^{[1
]}

Tricoli, James V. ^{[1
]}

Taylor, Jeremy M. G. ^{[9
]}

Shuman, Deborah J. ^{[1
]}

Simon, Richard M. ^{[1
]}

Doroshow, James H. ^{[1
]}

Conley, Barbara A. ^{[1
]}

机构：

[1] NCI, Div Canc Treatment & Diag, NIH, Bethesda, MD 20892 USA

[2] Univ N Carolina, Dept Pathol, Chapel Hill, NC 27599 USA

[3] Univ N Carolina, Lineberger Comprehens Canc Ctr, Chapel Hill, NC 27599 USA

[4] Univ Pittsburgh, Sch Med, Dept Pathol, Pittsburgh, PA 15213 USA

[5] Univ Pittsburgh, Sch Med, Inst Canc, Hillman Canc Ctr, Pittsburgh, PA 15213 USA

[6] NCI, Frederick Natl Lab Canc Res, NIH, Frederick, MD 21702 USA

[7] MIT, Broad Inst, Cambridge, MA 02142 USA

[8] Harvard Univ, Cambridge, MA 02142 USA

[9] Univ Michigan, Dept Biostat, Ann Arbor, MI 48109 USA

来源：

NATURE | 2013年 / 502卷 / 7471期

关键词：

MICROARRAY; BIOMARKERS;

D O I：

10.1038/nature12564

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

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.

引用

页码：317 / 320

页数：4

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