Talk:Imaging biomarker

Untitled

This article requires major editing.

Most importantly, it is misleading the reader in:

1) giving a very loose definition of the imaging biomarker. The strict definition is: "characteristics that are objectively measured and evaluated as indicators of normal biologic processes, pathological processes, or biological responses to a therapeutic intervention" [1].

2) claiming RECIST as a biomarker. RECIST is not a biomarker, tumor shrinkage is. RECIST is a tumor shrinkage response criteria considered appropriate by the FDA [2].

3) creating impression that there is a number of established imaging biomarkers, while in fact there is not a single one approved by regulatory agencies [3].

I do not have time to edit this extensively at the moment, but at the very least this note should be here to hopefully help the reader.

[1] U.S. Food and Drug Administration (2010) Guidance for Industry: Qualification Process for Drug Development Tools. Silver spring, MD: Center for Drug Evaluation and Research (CDER) 1-19.

[2] http://www.fda.gov/downloads/Drugs/.../Guidances/ucm071590.pdf

[3] Sanjay S. Imaging Biomarkers in Drug Development. Journal of Biomarkers in Drug Development. 2012; Available: http://www.scitechnol.com/JBDD/JBDD-1-e102.php?article_id=230