National Cancer Institute - NCI Division of Cancer Treatment and ...

Software and Technical
Report Archive
http://linus.nci.nih.gov/brb
The BRB Website contains other software,
such as software for the generation of
optimal and minimax two-stage phase II
clinical trial designs and software for
managing dose administration for patients
on accelerated titration design phase I
designs. The Website also contains technical
reports and PowerPoint presentations
of talks given by BRB staff. The technical
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sections are particularly rich in statistical
genomics material and are accessed
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28 ■ P R O G R A M A C C O M P L I S H M E N T S 2 0 0 6
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.)