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Imaging biomarkers exist and they underpin clinical decision-making

Nature Reviews Clinical Oncology volume 14, page 452 (2017)Cite this article

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A Corrigendum to this article was published on 17 October 2017

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We thank Dr Burke for his interest (Independent imaging biomarkers do not exist. Nat. Rev. Clin. Oncol. http://dx.doi.org/10.1038.nrclinonc.2016.162-c1; 2017)1 in the international consensus statement on 'imaging biomarker' translation2 that we led on behalf of Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC). The questions of what constitutes a biomarker, and what it means to validate a biomarker, have challenged medical researchers for over two decades3,4. These questions are not pedantic, and have substantial policy implications on how biomarker research should be conducted and funded, and how findings should be interpreted to improve health care. In his letter1, Dr Burke raises several questions, which we address herein.

The first question relates to the definition of biomarker. Ambiguities in biomarker-related terminology and confusion about evidence-based requirements for biomarker use have long existed. These issues were the motivating forces for the FDA and the NIH to support the development of the Biomarkers, Endpoints, and other Tools (BEST) Resource, in which a biomarker is described as “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions” (Ref. 4). The creators of the BEST Resource elaborate with the important insight that “molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers” (Ref. 4). This FDA–NIH definition is currently the leading available independent definition of a 'biomarker' and, therefore, has been used deliberately in our consensus statement in relation to imaging biomarkers.

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Change history

  • 17 October 2017

    In the HTML and PDF versions of this Correspondence, the authors declared no competing interests, but an involvement of John C. Waterton with Alderley Imaging Ltd and Bioxydyn Ltd was indicated in the author biographies section. This information has now also been incorporated into the competing interests statement in the HTML and PDF versions of the Correspondence.

References

  1. Burke, H. Independent imaging biomarkers do not exist. Nat. Rev. Clin. Oncol. http://dx.doi.org/10.1038.nrclinonc.2016.162-c1 (2017).

  2. O'Connor, J. P. et al. Imaging biomarker roadmap for cancer studies. Nat. Rev. Clin. Oncol. 14, 169–186 (2017).

    Article  CAS  Google Scholar 

  3. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 69, 89–95 (2001).

  4. FDA–NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) resource. NCBI http://www.ncbi.nlm.nih.gov/books/NBK326791 (2016).

  5. Weinreb, J. C. et al. PI-RADS prostate imaging — reporting and data system: 2015, version 2. Eur. Urol. 69, 16–40 (2016).

    Article  Google Scholar 

  6. Sullivan, D. C. et al. Metrology standards for quantitative imaging biomarkers. Radiology 277, 813–825 (2015).

    Article  Google Scholar 

  7. European Society of Radiology (ESR). ESR statement on the stepwise development of imaging biomarkers. Insights Imaging 4, 147–152 (2013).

  8. Prentice, R. L. Surrogate endpoints in clinical trials: definition and operational criteria. Stat. Med. 8, 431–440 (1989).

    Article  CAS  Google Scholar 

  9. Fleming, T. R. & DeMets, D. L. Surrogate end points in clinical trials: are we being misled? Ann. Intern. Med. 125, 605–613 (1996).

    Article  CAS  Google Scholar 

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Author information

Authors and Affiliations

  1. John C. Waterton is at the Centre for Imaging Sciences, University of Manchester, Oxford Road, Manchester M13 9PT, UK.,

    John C. Waterton

  2. Lisa M. McShane is at the Biometric Research Program, National Cancer Institute, 9609 Medical Center Drive, Bethesda, Maryland 20850, USA.,

    Lisa M. McShane

  3. James P. B. O'Connor is at the Division of Cancer Sciences, University of Manchester, Wilmslow Road, Manchester M20 4BX, UK.,

    James P. B. O'Connor

Authors
  1. John C. Waterton
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  2. Lisa M. McShane
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  3. James P. B. O'Connor
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Corresponding author

Correspondence to James P. B. O'Connor.

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Competing interests

J.C.W. was Director, shareholder and Chief Scientific Officer at Alderley Imaging Ltd, and is employed by Bioxydyn Ltd. L.M.MS. and J.P.B.OC. declare no competing interests.

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Waterton, J., McShane, L. & O'Connor, J. Imaging biomarkers exist and they underpin clinical decision-making. Nat Rev Clin Oncol 14, 452 (2017). https://doi.org/10.1038/nrclinonc.2017.84

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