Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration

Author:

McShane Lisa M,Cavenagh Margaret M,Lively Tracy G,Eberhard David A,Bigbee William L,Williams P Mickey,Mesirov Jill P,Polley Mei-Yin C,Kim Kelly Y,Tricoli James V,Taylor Jeremy MG,Shuman Deborah J,Simon Richard M,Doroshow James H,Conley Barbara A

Publisher

Springer Science and Business Media LLC

Subject

General Medicine

Reference105 articles.

1. Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials; Board on Health Care Services; Board on Health Sciences Policy; Institute of Medicine: Evolution of Translational Omics: Lessons Learned and the Path Forward. Edited by: Micheel CM, Nass S, Omenn GS. 2012, Washington, DC: The National Academies Press, http://www.iom.edu/Reports/2012/Evolution-of-Translational-Omics.aspx .

2. Poste G, Carbone DP, Parkinson DR, Verweij J, Hewitt SM, Jessup JM: Leveling the playing field: bringing development of biomarkers and molecular diagnostics up to the standards for drug development. Clin Cancer Res. 2012, 18: 1515-1523. 10.1158/1078-0432.CCR-11-2206.

3. McShane LM, Cavenagh MM, Lively T, Eberhard DA, Bigbee WL, Williams MP, Mesirov JP, Polley MY, Kim KY, Tricoli JV, et al: Criteria for the use of omics-based predictors in clinical trials. Nature. 2013, 502: 317-320. 10.1038/nature12564.

4. Apweiler R, Aslanidis C, Deufel T, Gerstner A, Hansen J, Hochstrasser D, Kellner R, Kubicek M, Lottspeich F, Maser E, Mewes HW, Meyer HE, Müllner S, Mutter W, Neumaier M, Nollau P, Nothwang HG, Ponten F, Radbruch A, Reinert K, Rothe G, Stockinger H, Tarnok A, Taussig MJ, Thiel A, Thiery J, Ueffing M, Valet G, Vandekerckhove J, Verhuven W, et al: Approaching clinical proteomics: current state and future fields of application in fluid proteomics. Clin Chem Lab Med. 2009, 47: 724-744.

5. Espina V, Mueller C, Edmiston K, Sciro M, Petricoin EF, Liotta LA: Tissue is alive: new technologies are needed to address the problems of protein biomarker pre-analytical variability. Proteom Clin Appl. 2009, 3: 874-882. 10.1002/prca.200800001.

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