参考文献

［1］李树婷.中国CRC的生态环境及SMO发展报告［J］.中国新药杂志，2018，27（11）：1-7.

［2］国家药品监督管理局.抗肿瘤药临床试验影像终点程序标准技术指导原则（征求意见稿）［R/OL］.（2020）［2020-7-26］.http：//www.cde.org.cn/zdyz.do？method＝largePage&id＝21d383137bb896f6.

［3］FDA.Guidance for industry，oversight of clinical investigations—a risk-based approach to monitoring［R/OL］.（2013）［2019-10-28］.https：//www.fda.gov/regulatory-information/search-fda-guidancedocuments/oversight-clinical-investigations-risk-based-approach-monitoring.

［4］FDA.Clinical trial imaging endpoint process standards guidance for industry［R/OL］.（2018）［2019-10-28］.https：//www.fda.gov/files/drugs/published/Clinical-Trial-Imaging-Endpoint-Process-Standards-Guidance-for-Industry.