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      The failure of protein cancer biomarkers to reach the clinic: why, and what can be done to address the problem?

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          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          There is a plethora of published cancer biomarkers but the reality is that very few, if any, new circulating cancer biomarkers have entered the clinic in the last 30 years. I here try to explain this apparent oxymoron by classifying circulating cancer biomarkers into three categories: fraudulent reports (rare); true discoveries of biomarkers, that then fail to meet the demands of the clinic; and false discoveries, which represent artifactual biomarkers. I further provide examples of combinations of some known cancer biomarkers that can perform well in niche clinical applications, despite individually being not useful.

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          Pivotal Evaluation of the Accuracy of a Biomarker Used for Classification or Prediction: Standards for Study Design

          Margaret S Pepe, Ziding Feng, Holly Janes … (2008)
          Research methods for biomarker evaluation lag behind those for evaluating therapeutic treatments. Although a phased approach to development of biomarkers exists and guidelines are available for reporting study results, a coherent and comprehensive set of guidelines for study design has not been delineated. We describe a nested case–control study design that involves prospective collection of specimens before outcome ascertainment from a study cohort that is relevant to the clinical application. The biomarker is assayed in a blinded fashion on specimens from randomly selected case patients and control subjects in the study cohort. We separately describe aspects of the design that relate to the clinical context, biomarker performance criteria, the biomarker test, and study size. The design can be applied to studies of biomarkers intended for use in disease diagnosis, screening, or prognosis. Common biases that pervade the biomarker research literature would be eliminated if these rigorous standards were followed.
          Article 0 comments Cited 189 times – based on 0 reviews     Review now
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            Cancer biomarkers: can we turn recent failures into success?

            Eleftherios P. Diamandis (2010)
            Disease biomarkers are used widely in medicine. But very few biomarkers are useful for cancer diagnosis and monitoring. Over the past 15 years, major investments have been made to discover and validate cancer biomarkers. Despite such investments, no new major cancer biomarkers have been approved for clinical use for at least 25 years. In the last decade, many reports have described new cancer biomarkers that promised to revolutionize the diagnosis of cancer and the management of cancer patients. However, many initially promising biomarkers have not been validated for clinical use. In this commentary, a plethora of parameters before sample analysis, during sample analysis, and after sample analysis that can complicate biomarker discovery and validation and lead to "false discovery" are discussed. Several examples of biomarker discoveries that were published in high-profile journals are also presented, as well as why they were not validated and the lessons learned from these false discoveries, so that similar mistakes can be avoided in the future.
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              Bias as a threat to the validity of cancer molecular-marker research.

              David F Ransohoff (2005)
              Claims that molecular markers can accurately diagnose cancer have recently been disputed; some prominent results have not been reproduced and bias has been proposed to explain the original observations. As new '-omics' fields are explored to assess molecular markers for cancer, bias will increasingly be recognized as the most important 'threat to validity' that must be addressed in the design, conduct and interpretation of such research.
              Article 0 comments Cited 88 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMC Med
                Journal ID (iso-abbrev): BMC Med
                Title: BMC Medicine
                Publisher: BioMed Central
                ISSN (Electronic): 1741-7015
                Publication date Collection: 2012
                Publication date (Electronic): 9 August 2012
                Volume: 10
                Page: 87
                Affiliations
                [1 ]Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto, ON, Canada
                [2 ]Department of Clinical Biochemistry, University Health Network, Toronto, ON, Canada
                [3 ]Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada
                Article
                Publisher ID: 1741-7015-10-87
                DOI: 10.1186/1741-7015-10-87
                PMC ID: 3425158
                PubMed ID: 22876833
                SO-VID: ca379d75-f49e-4d48-8ab2-7654c5614fab
                Copyright © Copyright ©2012 Diamandis; licensee BioMed Central Ltd.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 26 June 2012
                Date accepted : 9 August 2012
                Categories
                Subject: Commentary

                ScienceOpen disciplines: Medicine
                Keywords: improved biomarkers,biomarker validation,proteomics,cancer biomarkers,biomarker failures,false discovery
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: improved biomarkers, biomarker validation, proteomics, cancer biomarkers, biomarker failures, false discovery

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