Targeted Cancer Therapies Lagging

Hampton, Tracy
October 2006
JAMA: Journal of the American Medical Association;10/25/2006, Vol. 296 Issue 16, p1951
Academic Journal
The article states that the U.S. Food and Drug Administration has created a new program called the Critical Path Initiative to improve the preclinical and clinical testing of drugs and medical devices used in the molecular diagnosis and treatment of cancer. The initiative will use biomarkers to reveal the pathophysiology of a disease and whether a treatment is having a therapeutic effect. The Critical Path Initiative states that diagnostic and therapeutic studies should be designed and implemented together. The article states that the failure rate for oncology drugs is high, particularly in phase 3 clinical trials. Suggestions for improvements in the testing of targeted anticancer agents are provided. INSET: Improving Clinical Research.


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