Guidelines for Marker Development

Website: www.cancerdiagnosis.nci.nih.gov/assessment/progress/markerdev.html

A researcher, when undertaking identification of a potentially useful marker, must consider such questions as:

• Is there a biological rationale for this marker?
• Is there an assay system available that is working in at least one laboratory with reasonable reproducibility?
• Has the marker been examined in normal as well as abnormal/diseased tissue?
• Can a patient population be defined for which this marker may have utility? What is an expected range for the prevalence of this marker in populations of potential interest?
• Can the marker be measured in the types of specimens that will generally be available?

To assist researchers who are considering whether to proceed with development of a marker, the CDP-supported PACCT strategy group developed draft guidelines, which are available on the Web. The guidelines help researchers evaluate whether markers or assays are ready for use in clinical settings. It should be possible to determine what further steps need to be taken by critically examining available data. Some of this information has been incorporated into a journal article: Hammond ME, Taube SE. Issues and barriers to development of clinically useful tumor markers: a development pathway proposal. Semin Oncol 2002:29;213–21.