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REporting recommendations for tumor MARKer prognostic studies (REMARK)


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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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.

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Correspondence to Lisa M McShane.

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The author declare no competing financial interests.



Consolidated Standards of Reporting Trials


Standards for Reporting of Diagnostic Accuracy


Quality of Reporting of Meta-analyses


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).

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