Last Updated: 04/06/07
Guidelines for Tumor Biomarker Studies
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, initial 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.
The development of guidelines for the reporting of tumor marker studies was a major recommendation of the NCI-European Organisation for Research and Treatment of Cancer at the First International Meeting on Cancer Diagnostics in 2000. BRB collaborated with CDP staff and extramural statisticians to develop publication guidelines for the REporting of tumor MARKer studies (REMARK) to provide relevant information about the study design, prespecified hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. 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 judge the usefulness of the data and understand the context in which the conclusions apply.
The REMARK guidelines were published in the Journal of Clinical Oncology and may be accessed through the journal’s Website: http://www.jco.org/cgi/content/full/23/36/9067. (McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, Clark GM. Reporting recommendations for tumor marker prognostic studies. J Clin Oncol 2005:23;9067-72.)
