Abstract
The era of Personalized Medicine implies getting the right treatment to the right patient at the right schedule and dose at the right time. Tumor biomarker tests are keys to accomplishing this goal successfully. However, much of the translational research regarding tumor biomarker tests has been haphazard, often using data and specimen sets of convenience and ignoring many of the principles of the scientific method. In papers published simultaneously in BMC Medicine and Nature, McShane and colleagues have proposed a checklist of criteria that should be followed by investigators planning to conduct prospective clinical trials directed towards generating high levels of evidence to demonstrate whether a tumor biomarker test has clinical utility for a specific context. These criteria were generated in response to a roadmap reported by a committee convened by the U.S. Institute of Medicine for generation of omics-based biomarker tests. Taken together with several other initiatives to increase the rigor of tumor biomarker research, these criteria will increase the perception of value for tumor biomarker test research and application in the clinic.Please see related article: http://www.biomedcentral.com/1741-7015/11/220.
Highlights
Over the last few years, one cannot open a clinical journal without an article ostensibly addressing some component of ‘Personalized’ or ‘Individualized’ or ‘Precision’ medicine
A roadmap for the improvement of tumor biomarker research In a correspondence article in BMC Medicine [16], and in an accompanying companion paper published simultaneously in Nature [17], McShane and her colleagues extend these efforts to improve tumor biomarker research by providing a checklist of criteria for the use of omicsbased predictors in clinical trials. This checklist grew out of a workshop convened by the United States National Cancer Institute (NCI), to consider the recommendations from the Institute of Medicine (IOM) committee
The NCI Workshop criteria proposed by McShane et al, which are carefully explained in the BMC Medicine Explanation and Elaboration article [16], represent a further effort to provide a ‘tour guide’ to accompany the roadmap laid out by the IOM Committee
Summary
Over the last few years, one cannot open a clinical journal without an article ostensibly addressing some component of ‘Personalized’ or ‘Individualized’ or ‘Precision’ medicine. High levels of evidence may come either from prospectively directed clinical trials [14,15] or from ‘prospective retrospective’ studies using archived specimens derived from previously conducted clinical trials [11] These concepts apply to any diagnostic in general, and to any tumor biomarker the advent of omics-based tumor biomarker studies has led to a plethora of reports of putative assays that are highly confounded by the astounding number of data points applied to a vanishingly small patient dataset. A roadmap for the improvement of tumor biomarker research In a correspondence article in BMC Medicine [16], and in an accompanying companion paper published simultaneously in Nature [17], McShane and her colleagues extend these efforts to improve tumor biomarker research by providing a checklist of criteria for the use of omicsbased predictors in clinical trials This checklist grew out of a workshop convened by the United States National Cancer Institute (NCI), to consider the recommendations from the IOM committee. The NCI Workshop criteria proposed by McShane et al, which are carefully explained in the BMC Medicine Explanation and Elaboration article [16], represent a further effort to provide a ‘tour guide’ to accompany the roadmap laid out by the IOM Committee
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