Cited by 2,162Meta-analysis and systematic reviewsStatistical Methods in EpidemiologyCancer Diagnosis and Treatment

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Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK)

McShane, Lisa M., Altman, Douglas G., Sauerbrei, Willi, Taube, Sheila E., Gion, Massimo, Clark, Gary M.·2005·JNCI: Journal of the National Cancer Institute

DOI 10.1093/jnci/dji237

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Abstract

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, 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.

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Authors: McShane, L. M., Altman, D. G., Sauerbrei, W., Taube, S. E., Gion, M., & Clark, G. M.
Affiliations: National Institutes of Health (US)
Corresponding author: McShane, Lisa M.
ORCID: McShane, Lisa M.
Altman, Douglas G.
Sauerbrei, Willi
Gion, Massimo
Clark, Gary M.
Venue: JNCI: Journal of the National Cancer Institute
Publisher: Oxford University Press (OUP)
Published: 2005-08-17
Volume: 97
Issue: 16
Pages: 1180-1184
ISSN: 0027-8874 (ISSN-L)
1460-2105
DOI: 10.1093/jnci/dji237
OpenAlex: W2096910745
Cited by: 2,162
References: 46
Citations by year: 2026: 112 · 2025: 38 · 2024: 44 · 2023: 42 · 2022: 39 · 2021: 93 · 2020: 100 · 2019: 126 · 2018: 116 · 2017: 127 · 2016: 163 · 2015: 192 · 2014: 167 · 2013: 150 · 2012: 173
FWCI: 56.89
Type: journal article
Language: en
Open access: closed
Locations: JNCI Journal of the National Cancer Institute (publishedVersion)
PubMed (publishedVersion)
Funders: Yale University
Yale Cancer Center
Cancer Research UK
Translational Cancer Research Network
National Cancer Institute (MD 20892, 20892)
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Health Sciences › Medicine › Oncology › Cancer Diagnosis and Treatment
Keywords: tumor markers, prognostic factors, reporting guidelines, remarks, reporting quality, methodological discrepancies, research design, assay method, statistical analysis methods, cancer diagnosis, research transparency
MeSH terms: Humans, Neoplasms, Research Design, Biomarkers, Tumor, Information Dissemination, Biomedical Research

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Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK)

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