REporting recommendations for tumor MARKer prognostic studies (REMARK)
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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 that multiple studies of the same marker lead to differing conclusions. A variety of methodologic 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, pre-planned 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.
KeywordsTumor markers Guidelines NCI EORTC REMARK Prognostic
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We are grateful to the U.S. 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 U.K. National Translational Cancer Research Network for financial support provided to D. G. Altman. Members of the Statistics Subcommittee of the NCI-EORTC Working Group on Cancer Diagnostics are: Douglas G. Altman, D.Sc. (Co-chair), Cancer Research UK Medical Statistics Group, Centre for Statistics in Medicine, Wolfson College, Oxford OX2 6UD, UK; Lisa M. McShane, Ph.D. (Co-chair), Biometric Research Branch, U.S. National Cancer Institute, Bethesda, MD 20892; Gary M. Clark, Ph.D., OSI Pharmaceuticals, Inc. Boulder, CO 80301; Jose Costa, M.D., Yale Cancer Center, New Haven, CT 06510-3202; Angelo Di Leo, M.D., Ph.D., Department of Oncology, Hospital of Prato, 59100 Prato, Italy; Massimo Gion, M.D., Centro Regionale Indicatori Biochimici di Tumore, Ospedale Civile, 30122 Venezia, Italy; Robert J. Mayer, M.D., Dana-Farber Cancer Institute, Boston, MA 02115; Willi Sauerbrei Ph.D., Institut fuer Medizinische Biometrie und Medizinische Informatik, Universitaetsklinikum Freiburg, 79104 Freiburg, Germany; Sheila E. Taube, Ph.D., Cancer Diagnosis Program, U.S. National Cancer Institute, Bethesda, MD 20892.
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