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© 2005 Oxford University Press
COMMENTARY |
Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK)
for the Statistics Subcommittee of the NCI-EORTC Working Group on Cancer Diagnostics
Affiliations of authors: Biometric Research Branch (LMM) and Cancer Diagnosis Program (SET), National Cancer Institute, Bethesda, MD; Medical Statistics Group, Cancer Research UK, Center for Statistics in Medicine, Wolfson College, Oxford, UK (DGA); Institut fuer Medizinische Biometrie und Medizinische Informatik, Universitaetsklinikum Freiburg, Germany (WS); Centro Regionale Indicatori Biochimici di Tumore, Ospedale Civile, Venezia, Italy (MG); OSI Pharmaceuticals, Inc., Boulder, CO (GMC)
Correspondence to: Lisa M. McShane, PhD, National Cancer Institute, Biometric Research Branch, DCTD, Rm. 8126, Executive Plaza North, MSC 7434, 6130 Executive Blvd., Bethesda, MD 20892-7434 (e-mail: lm5h{at}nih.gov).
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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- Re: Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK)
- Sanjay Popat and Richard S. Houlston
J Natl Cancer Inst 2005 97: 1855.[Extract] [Full Text] [PDF]
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|
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|
|
|
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|
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|
|
|
|
|
|
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|
|
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|
|
|
|
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|
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|
|
|
|
 |
|
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|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
 |
|
 M. Mupparapu and I. H. Kim Calcified carotid artery atheroma and stroke: A systematic review J Am Dent Assoc, April 1, 2007; 138(4): 483 - 492. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
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|
|
|
|
|
|
P. A. Kyzas, D. Denaxa-Kyza, and J. P. A. Ioannidis Quality of Reporting of Cancer Prognostic Marker Studies: Association With Reported Prognostic Effect J Natl Cancer Inst, February 7, 2007; 99(3): 236 - 243. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
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|
|
|
|
|
|
S Popat, Z Chen, D Zhao, H Pan, N Hearle, I Chandler, Y Shao, W Aherne, and R. Houlston A prospective, blinded analysis of thymidylate synthase and p53 expression as prognostic markers in the adjuvant treatment of colorectal cancer Ann. Onc., December 1, 2006; 17(12): 1810 - 1817. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Costa, M. G. Daidone, L. Daprai, R. Villa, S. Cantu, S. Pilotti, L. Mariani, A. Gronchi, J. D. Henson, R. R. Reddel, et al. Telomere Maintenance Mechanisms in Liposarcomas: Association with Histologic Subtypes and Disease Progression. Cancer Res., September 1, 2006; 66(17): 8918 - 8924. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
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|
|
|
|
|
|
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|
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