Cancer Prevention Clinical Trials Monitoring and Informatics Support

美国国家癌症研究所癌症预防部（NCI DCP）支持的科学不仅寻求识别那些处于发展癌症高风险的人，而且还寻求识别和开发化学预防和其他干预措施，这些干预措施将抑制，消退，逆转，预防或延迟这些癌症的发生。NCI DCP管理一系列科学和临床活动，包括识别和优先考虑具有潜在癌症预防活性的药物，选择药物进行开发，进行临床前研究，进行I期和II期测试，并将有前途的药物转移到更大的III期癌症预防临床试验中。这些癌症预防试验由国家和国际临床研究中心的校外研究人员进行。 作为试验的申办者，NCI DCP负责确保临床试验从最初的安全性研究到新药物或干预措施在预防特定类型癌症中的作用的最终评估安全地进行。履行这一责任需要在整个过程中对临床试验进行仔细和彻底的监测，包括验证研究者是否符合方案、药物临床试验质量管理规范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支持合同为NCI DCP赞助的I期、II期和选定的III期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 to identify and develop chemopreventive and other interventions that will inhibit, regress, reverse, prevent or delay the incidence of these cancers. 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 testing 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 that includes verifying 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.