REporting recommendations for tumor MARKer prognostic studies (REMARK)
- First Online:
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
Unable to display preview. Download preview PDF.
- 2.Bast RC Jr, Ravdin P, Hayes DF, Bates S, Fritsche H Jr, Jessup JM et al for the American Society of Clinical Oncology Tumor Markers Expert Panel (2001). 2000 update of recommendations for the use of tumor markers in breast and colorectal cancer: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol 19:1865–1878PubMedGoogle Scholar
- 28.Altman DG (2001) Systematic reviews of evaluations of prognostic variables. In: Egger M, Davey Smith G, Altman DG (eds) Systematic reviews in health care. Meta−analysis in context. 2nd edn. BMJ Books, London pp 228–247Google Scholar
- 30.McShane LM, Simon R (2001) Statistical methods for the analysis of prognostic factor studies. In: Gospodarowicz MK, Henson DE, Hutter RVP, O’Sullivan B, Sobin LH, Wittekind Ch (eds) Prognostic factors in cancer. 2nd edn. Wiley-Liss, New York pp 37–48Google Scholar
- 31.Simon R (2001) Evaluating prognostic factor studies. In: Gospodarowicz MK, Henson DE, Hutter RVP, O’Sullivan B, Sobin LH, Wittekind Ch (eds) Prognostic factors in cancer. 2nd edn. Wiley-Liss, New York pp 49–56Google Scholar
- 33.Schumacher M, Hollander N, Schwarzer G, Sauerbrei W (2006) Prognostic factor studies. In: Crowley J, Ankerst DP (eds) Handbook of statistics in clinical oncology. Boca Raton: Chapman & Hall/CRC Press, pp 289–333Google Scholar
- 34.Moher D, Schulz KF, Altman D for the CONSORT Group (2001) The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. JAMA 285:1987–1991Google Scholar
- 38.Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup D for the QUOROM Group (1999) Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Lancet 354:1896–1900Google Scholar