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

McShane, LM and Cavenagh, MM and Lively, TG and Eberhard, DA and Bigbee, WL and Williams, PM and Mesirov, JP and Polley, MYC and Kim, KY and Tricoli, JV and Taylor, JMG and Shuman, DJ and Simon, RM and Doroshow, JH and Conley, BA (2013) Criteria for the use of omics-based predictors in clinical trials: Explanation and elaboration. BMC Medicine, 11 (1).

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Abstract

High-throughput 'omics' technologies that generate molecular profiles for biospecimens have been extensively used in preclinical studies to reveal molecular subtypes and elucidate the biological mechanisms of disease, and in retrospective studies on clinical specimens to develop mathematical models to predict clinical endpoints. Nevertheless, the translation of these technologies into clinical tests that are useful for guiding management decisions for patients has been relatively slow. It can be difficult to determine when the body of evidence for an omics-based test is sufficiently comprehensive and reliable to support claims that it is ready for clinical use, or even that it is ready for definitive evaluation in a clinical trial in which it may be used to direct patient therapy. Reasons for this difficulty include the exploratory and retrospective nature of many of these studies, the complexity of these assays and their application to clinical specimens, and the many potential pitfalls inherent in the development of mathematical predictor models from the very high-dimensional data generated by these omics technologies. Here we present a checklist of criteria to consider when evaluating the body of evidence supporting the clinical use of a predictor to guide patient therapy. Included are issues pertaining to specimen and assay requirements, the soundness of the process for developing predictor models, expectations regarding clinical study design and conduct, and attention to regulatory, ethical, and legal issues. The proposed checklist should serve as a useful guide to investigators preparing proposals for studies involving the use of omics-based tests. The US National Cancer Institute plans to refer to these guidelines for review of proposals for studies involving omics tests, and it is hoped that other sponsors will adopt the checklist as well. © 2013 McShane et al.; licensee BioMed Central Ltd.


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Details

Item Type: Article
Status: Published
Creators/Authors:
CreatorsEmailPitt UsernameORCID
McShane, LM
Cavenagh, MM
Lively, TG
Eberhard, DA
Bigbee, WL
Williams, PM
Mesirov, JP
Polley, MYC
Kim, KY
Tricoli, JV
Taylor, JMG
Shuman, DJ
Simon, RM
Doroshow, JH
Conley, BA
Centers: Other Centers, Institutes, or Units > Hillman Cancer Center
Other Centers, Institutes, or Units > Pittsburgh Cancer Institute
Date: 17 October 2013
Date Type: Publication
Journal or Publication Title: BMC Medicine
Volume: 11
Number: 1
DOI or Unique Handle: 10.1186/1741-7015-11-220
Schools and Programs: School of Medicine > Pathology
Refereed: Yes
Article Type: Correspondence/Letter
Date Deposited: 28 Sep 2016 18:26
Last Modified: 29 Jan 2019 15:55
URI: http://d-scholarship.pitt.edu/id/eprint/29667

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