Cancer Prevention Clinical Trials Monitoring and Informatics Support

国家癌症研究所癌症预防部门(NCI DCP)支持这样的科学，即不仅寻求识别癌症高危人群，而且识别和开发化学预防和其他干预措施，以抑制、逆转、逆转、预防或延缓癌症的发生。NCI DCP管理着一系列科学和临床活动，包括确定具有潜在癌症预防活性的药物并确定其优先顺序，选择用于开发的药物，进行临床前研究，进行测试试剂的第一阶段和第二阶段试验，以及将有希望的药物转移到更大的第三阶段癌症预防临床试验。这些癌症预防试验是由外部研究人员在国内和国际临床地点进行的。 作为试验的赞助商，NCI DCP负责确保临床试验从最初的安全性研究到对新制剂或干预措施在预防特定类型癌症中的作用的最终评估，都是安全和按照协议进行的。履行这一责任需要对临床试验的整个过程进行仔细和彻底的监测，包括验证临床试验数据以及研究人员遵守方案、良好临床实践指南和适用的法规要求和临床试验政策。癌症预防临床试验监测和信息学支持合同为NCI DCP赞助的第一阶段、第二阶段和选定的第三阶段癌症预防临床试验提供全面的临床试验监督能力。

The National Cancer Institute Division of Cancer Prevention (NCI DCP) supports science that seeks not only to identify those at high risk of developing cancer, but also to identify and develop chemopreventive and other interventions that will inhibit, regress, reverse, prevent or delay the incidence of cancer. NCI DCP manages a portfolio of scientific and clinical activities which includes identifying and prioritizing agents with potential cancer prevention activity, selecting agents for development, performing pre-clinical studies, conducting Phase I and Phase II trials for testing agents, and moving promising agents into larger Phase III cancer prevention clinical trials. These cancer prevention trials are conducted by extramural investigators at national and international clinical sites. As sponsor of a trial, NCI DCP is responsible for ensuring that clinical trials are conducted safely and according to protocol from the initial safety studies through the definitive evaluation of the role of the new agent or intervention in the prevention of specific types of cancer. Fulfillment of this responsibility requires careful and thorough monitoring of a clinical trial throughout its entire process including the verification of clinical trials data as well as investigator compliance with the protocol, Good Clinical Practice Guidelines and applicable regulatory requirements and clinical trials policies. The Cancer Prevention Clinical Trials Monitoring and Informatics Support contract provides comprehensive clinical trial oversight capability for the Phase I, Phase II, and selected Phase III cancer prevention clinical trials sponsored by NCI DCP.