Imaging as a tumor biomarker in oncology drug trials for lung cancer: the FDA perspective.
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.
Petrick
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National Institute of Biomedical Imaging and Bioengineering/Center for Devices and Radiological Health Laboratory for the Assessment of Medical Imaging Systems, US Food and Drug Administration, Silver Spring, Maryland, USA. nicholas.petrick@fda.hhs.gov
Brown
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Suleiman
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Myers
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D000970:Antineoplastic Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D003952:Diagnostic Imaging; D017277:Drug Approval; D006801:Humans; D008175:Lung Neoplasms / Q000000981:diagnostic imaging* / Q000188:drug therapy / Q000473:pathology*; D009316:National Institutes of Health (U.S.); D019047:Phantoms, Imaging; D011379:Prognosis; D012107:Research Design; D012984:Software / Q000592:standards; D014057:Tomography, X-Ray Computed / Q000295:instrumentation / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
D000970:Antineoplastic Agents