成像作为肺癌肿瘤药物试验中的肿瘤生物标志物：美国食品药品监督管理局的观点

Imaging as a tumor biomarker in oncology drug trials for lung cancer: the FDA perspective.

作者信息

Petrick N, Brown D G, Suleiman O, Myers K J

机构信息

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.

出版信息

Clin Pharmacol Ther. 2008 Oct;84(4):523-5. doi: 10.1038/clpt.2008.155.

DOI:10.1038/clpt.2008.155

PMID:18716616

Abstract

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.

摘要

鉴于实验室正在研发的众多有前景的新型肿瘤药物，以及这些新药惠及患者群体所需的时间和费用，美国食品药品监督管理局（FDA）致力于与肿瘤学界合作，加快药物评估进程。一项重大进展将是使定量成像成为一种肿瘤生物标志物。FDA主要通过合作开展教育和研究工作，与制药行业、学术界以及政府内的相关利益方共同努力，以确定成像如何能够发挥这一作用。