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REporting recommendations for tumour MARKer prognostic studies (REMARK)
LM McShane, DG Altman, W Sauerbrei, SE Taube, M Gion and GM Clark for the Statistics Subcommittee of the NCI-EORTC Working Group on Cancer Diagnostics
Download REMARK checklist
The goal of the REMARK recommendations for tumor marker prognostic studies is to encourage transparent and complete reporting. Adherence to REMARK will ensure that relevant information is available to help investigators judge the usefulness of the data and understand the context in which the conclusions apply. The guidelines were primarily developed for studies evaluating a single tumour marker of interest. However, they are generally relevant for studies examining more than one marker. They are not intended for reporting the development of complex prognostic models such as those built from very large numbers of candidate markers, although many elements are relevant to such studies too.
A checklist with 20 items (1- Introduction, 10- Materials and Methods, 7- Results, 2- Discussion) is provided. An explanatory paper that will provide further rationale and specific examples of types of information to be reported for each item is in preparation (expected publication by end of 2009). The REMARK study profile will be introduced in the explanatory paper as a means of providing (a) a succinct summary of the types of patients and variables included in a study and (b) an outline of the series of analyses that were conducted to obtain the reported results (and the data available for each analysis). The latter is particularly important as often in prognostic marker studies many analyses are done but few are adequately reported.
Development of the guidelines was initiated in 2000 at a joint meeting of the US National Cancer Institute and the European Organisation for Research and Treatment of Cancer (NCI-EORTC). A working group was charged with addressing statistical issues of poor design, analysis and reporting of tumor marker prognostic studies. Published reports of methodologic problems in the conduct of tumor marker studies and deficiencies in study reporting formed the basis for early discussions of the working group. These discussions led to a first draft of reporting guidelines that was posted on the website of the Program for the Assessment of Clinical Cancer Tests (PACCT) Strategy Group of the US National Cancer Institute (http://www.cancerdiagnosis.nci.nih) and circulated to attendees of the NCI-EORTC Second International Meeting on Cancer Diagnostics in 2002. An improved version was developed and sent to the full committee. Comments were incorporated into a final version which was approved by the full committee.
In 2005 the REMARK guidelines were published simultaneously in the following five journals
- British Journal of Cancer 2005;93(4):387-91.
- Journal of the National Cancer Institute 2005;97(16):1180-84.
- European Journal of Cancer 2005;41(12):1690-96.
- Journal of Clinical Oncology 2005;23(36): 9067-72.
- Nature Clinical Practice Oncology 2005;2(8):416-22.
- Experimental Oncology 2006;28(2):99-105.
- Breast Cancer Research and Treatment 2006;100(2):229-35.
Editorials or comments promoting the guidelines
- Popat S, Houlston RS. Re: Reporting recommendations for tumor marker prognostic studies (REMARK). J Natl Cancer Inst 2005;97:1855; author reply 1855-6.
- Alonzo TA. Standards for reporting prognostic tumor marker studies. J Clin Oncol 2005;23:9053-4.
- Harris AL. REporting recommendations for tumour MARKer prognostic studies (REMARK). Br J Cancer 2005;93:385-6.
- Katz EM, Kattan MW. How to judge a tumor marker. Nat Clin Pract Oncol 2005;2:482-3.
- News. New guidelines for marker studies. European Journal of Cancer 2005;41:1661.
- Hayes DF, Ethier S, Lippman ME. New guidelines for reporting of tumor marker studies in breast cancer research and treatment: REMARK. Breast Cancer Res Treat 2006;100:237-8.
Journals' instructions to authors
So far (November 2008) REMARK is mentioned in the guidelines for authors in
- Journal of Clinical Oncology
- Breast Cancer Research and Treatment.
- [to be updated]
Page last edited: 04 August 2011