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

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 M. G.,Shuman Deborah J.,Simon Richard M.,Doroshow James H.,Conley Barbara A.

Publisher

Springer Science and Business Media LLC

Subject

Multidisciplinary

Reference19 articles.

1. Institute of Medicine. Evolution of Translational Omics: Lessons Learned and the Path Forward (eds Micheel, C. M., Nass, S. & Omenn, G. S. ) (The National Academies Press, 2012)A report produced by a committee formed in response to an NCI request for recommendations to strengthen omics-based test development and evaluation; this identifies best practices to enhance the development, evaluation and translation of omics-based tests while reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

2. McShane, L. M. et al. Criteria for the use of omics-based predictors in clinical trials: explanation & elaboration. BMC Med.11, 220 (2013)This paper is an annotated companion to the short version of the guidelines presented here, elucidating the rationale underlying the development of the criteria in greater detail.

3. Moore, H. M. et al. Biospecimen Reporting for Improved Study Quality (BRISQ). Cancer Cytopath.119, 92–101 (2011)

4. Dobbin, K. K. et al. Interlaboratory comparability study of cancer gene expression analysis using oligonucleotide microarrays. Clin. Cancer Res.11, 565–572 (2005)

5. Shi, L. et al. The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.Nature Biotechnol.24, 1151–1161 (2006)

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