Abstract
Despite years of research and hundreds of reports on tumour 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 tumour 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 generalisability of study results. The development of guidelines
for the reporting of tumour 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 randomised 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.
Keywords
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Article info
Publication history
Accepted:
March 31,
2005
Received:
January 8,
2005
Identification
Copyright
© 2005 Douglas G. Altman DSc, Gary M. Clark PhD, Dr. Massimo Gion, and Dr. Willi Sauerbrei. Published by Elsevier Inc. All rights reserved.
