Guidelines for the National Cancer Institute (NCI) Experimental Therapeutics Clinical Trials Network (ETCTN) have been developed by NCI staff of the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), in consultation with staff of the NCI Office of Grants Administration (OGA) and the NCI Division of Extramural Activities (DEA),as well as with the advice校外科学界的合格成员。目的是描述参与该计划的各种申请人和调查人员,同伴审稿人以及美国国立卫生研究院(NIH)的目标和期望。They are intended to encourage an innovative, state-of-the-art experimental therapeutics clinical trials program executed by an integrated network of investigators and participating institutions who are experienced in conducting early phase clinical trials with emphasis on molecular characterization, biomarker assays, pharmacogenomics, integral and integrated assay development, pharmacodynamics (PD), pharmacokinetics (PK), and advanced imaging technology.有关PK实验室的更多信息,请参阅https://ctep.cancer.gov/initiativesprograms/etctn.htm的实验治疗临床试验网络(ETCTN)药代动力学资源实验室指南。ETCTN包括NCI CTEP阶段1和2阶段临床试验计划,并补充了国家临床试验网络(NCTN),该试验的重点是晚期发展,重点是第3阶段,特定于疾病的研究。参与者与NCI sta效率合作以实现ETCTN目标。此指南文件分为三个部分:ETCTN的最终目的是基于分子表征和生物标志物测定开发用于早期实验性治疗临床试验的新方法进行癌症治疗方法。NCI为数据管理,临床试验注册,监管支持和中央机构审查委员会(CIRB)审查等活动提供了集中的支持。
主要关键词