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Imaging as a Tumor Biomarker in Oncology Drug Trials for Lung Cancer: The FDA Perspective
Author(s) -
Petrick N,
Brown DG,
Suleiman O,
Myers KJ
Publication year - 2008
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2008.155
Subject(s) - medicine , drug development , biomarker , food and drug administration , clinical trial , clinical pharmacology , oncology , clinical research , drug , clinical oncology , lung cancer , medical physics , perspective (graphical) , precision oncology , companion diagnostic , population , cancer drugs , pharmacology , cancer , computer science , environmental health , biochemistry , chemistry , artificial intelligence
The US Food and Drug Administration (FDA) is committed to working with the oncology community to expedite the drug evaluation process in view of the many promising new oncology drugs under laboratory development and the time and expense required for such new drugs to reach the patient population. One significant advance would be to enable quantitative imaging as a tumor biomarker. The FDA is working with the pharmaceutical industry, academia, and sister stakeholders in the government, primarily through collaborative educational and research efforts, to identify how imaging can serve this function. Clinical Pharmacology & Therapeutics (2008); 84 , 4, 523–525 doi: 10.1038/clpt.2008.155