Talk:Imaging biomarker
This article is rated Start-class on Wikipedia's content assessment scale. It is of interest to the following WikiProjects: | |||||||||||||||||
|
Untitled
[edit]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
- Start-Class medicine articles
- Mid-importance medicine articles
- Start-Class hematology-oncology articles
- Mid-importance hematology-oncology articles
- Hematology-oncology task force articles
- Start-Class radiology articles
- Mid-importance radiology articles
- Radiology task force articles
- All WikiProject Medicine pages