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REporting recommendations for tumor MARKer prognostic studies (REMARK)

Nature Clinical Practice Oncology volume 2, pages 416–422 (2005)Cite this article

Abstract

Despite years of research and hundreds of reports on tumor markers in oncology, the number of markers that have emerged as clinically useful is pitifully small. Often initially reported studies of a marker show great promise, but subsequent studies on the same or related markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons why multiple studies of the same marker lead to differing conclusions. A variety of methodological problems have been cited to explain these discrepancies. Unfortunately, many tumor marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalizability of study results. The development of guidelines for the reporting of tumor marker studies was a major recommendation of the National Cancer Institute–European Organisation for Research and Treatment of Cancer (NCI–EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines provide helpful suggestions on how to present data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.boxed-text

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Acknowledgements

We are grateful to the US National Cancer Institute and the European Organisation for Research and Treatment of Cancer for their support of the NCI–EORTC International Meetings on Cancer Diagnostics from which the idea for these guidelines originated. We thank the UK National Translational Cancer Research Network for financial support provided to DG Altman.

Author information

Authors and Affiliations

  1. Senior Statistician in the Biometric Research Branch at the National Cancer Institute, Bethesda, Maryland, USA

    Lisa M McShane

  2. Professor of Statistics in Medicine at the Centre for Statistics in Medicine, Oxford, UK

    Douglas G Altman

  3. Senior Statistician in the Institute for Medical Biometry and Medical Informatics at the University Hospital of Freiburg, Freiburg, Germany

    Willi Sauerbrei

  4. Director of the Division of Cancer Treatment and Diagnosis, Cancer Diagnosis Program, at the National Cancer Institute, Bethesda, Maryland, USA

    Sheila E Taube

  5. Center for Study of Biological Markers of Malignancy,

    Massimo Gion

  6. Unit of Laboratory Medicine at Regional General Hospital, Venice, Italy

    Massimo Gion & Massimo Gion

  7. Vice President, Biostatistics and Data Management, OSI Pharmaceuticals, Inc., Boulder, Colorado, USA

    Gary M Clark

Consortia

for the Statistics Subcommittee of the NCI—EORTC Working Group on Cancer Diagnostics

  • Lisa M McShane
  • , Douglas G Altman
  • , Willi Sauerbrei
  • , Sheila E Taube
  • , Massimo Gion
  •  & Gary M Clark

Corresponding author

Correspondence to Lisa M McShane.

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Competing interests

The author declare no competing financial interests.

Glossary

CONSORT

Consolidated Standards of Reporting Trials

STARD

Standards for Reporting of Diagnostic Accuracy

QUOROM

Quality of Reporting of Meta-analyses

MOOSE

Meta-analysis Of Observational Studies in Epidemiology

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for the Statistics Subcommittee of the NCI—EORTC Working Group on Cancer Diagnostics. REporting recommendations for tumor MARKer prognostic studies (REMARK). Nat Rev Clin Oncol 2, 416–422 (2005). https://doi.org/10.1038/ncponc0252

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  • DOI: https://doi.org/10.1038/ncponc0252

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