Guidelines

BJC Open article

British Journal of Cancer (2005) 93, 387–391. doi:10.1038/sj.bjc.6602678 www.bjcancer.com
Published online 2 August 2005

REporting recommendations for tumour MARKer prognostic studies (REMARK)

L M McShane1, D G Altman2, W Sauerbrei3, S E Taube1, M Gion4 and G M Clark5 for the Statistics Subcommittee of the NCI-EORTC Working Group on Cancer Diagnostics6

  1. 1US National Cancer Institute, Bethesda, MD 20892, USA
  2. 2Cancer Research UK Medical Statistics Group, Centre for Statistics in Medicine, Wolfson College, Oxford OX2 6UD, UK
  3. 3Institut fuer Medizinische Biometrie und Medizinische Informatik, Universitaetsklinikum Freiburg, 79104 Freiburg, Germany
  4. 4Centro Regionale Indicatori Biochimici di Tumoure, Ospedale Civile, 30122 Venezia, Italy
  5. 5OSI Pharmaceuticals, Inc., Boulder, CO 80301, USA

Correspondence: Dr LM McShane, National Cancer Institute, Biometric Research Branch, DCTD, Room 8126, Executive Plaza North, MSC 7434, 6130 Executive Boulevard, Bethesda, MD 20892-7434, USA. E-mail: Lm5h@nih.gov

6Members of the Statistics Subcommittee of the NCI/EORTC Working Group on Cancer Diagnostics: Douglas G Altman DSc (Co-chair), Cancer Research UK Medical Statistics Group, Centre for Statistics in Medicine, Wolfson College, Oxford OX2 6UD, UK; Lisa M McShane, PhD (Co-chair), US National Cancer Institute, Bethesda, MD 20892, USA; Gary M Clark, PhD, OSI Pharmaceuticals, Inc., Boulder, CO 80301, USA; Jose Costa, MD, Yale Cancer Center, New Haven, CT 06510-3202, USA; Angelo Di Leo, MD, PhD, Department of Oncology, Hospital of Prato, 59100 Prato, Italy; Massimo Gion, MD, Centro Regionale Indicatori Biochimici di Tumoure, Ospedale Civile, 30122 Venezia, ItalyRobert J Mayer, MD, Dana-Farber Cancer Institute, Boston, MA 02115, USA; Willi Sauerbrei, PhD, Institut fuer Medizinische Biometrie und Medizinische Informatik, Universitaetsklinikum Freiburg, 79104 Freiburg, Germany; Sheila E Taube, Ph.D., US National Cancer Institute, Bethesda, MD 20892, USA

Received 5 January 2005; Revised 18 May 2005; Accepted 25 May 2005
Advance online publication 2 August 2005

In order to encourage dissemination of the guidelines set out in this paper, it is freely accessible on the BJC website (www.bjcancer.com), and will also be published simultaneously in the European Journal of Cancer, Journal of Clinical Oncology, Journal of the National Cancer Institute, and Nature Clinical Practice Oncology.

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Abstract

Despite years of research and hundreds of reports on tumour 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 that multiple studies of the same marker lead to differing conclusions. A variety of methodological problems have been cited to explain these discrepancies. Unfortunately, many tumour 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 generalisability of the study results. The development of guidelines for the reporting of tumour marker studies was a major recommendation of the US National Cancer Institute and the European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. Similar to the successful CONSORT initiative for randomised trials and 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 suggest helpful presentations of 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.

Keywords:

tumour marker; guidelines; REMARK; NCI; EORTC; prognostic

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