CANCER PREVENTION CLINICAL TRIALS AUDITING & INFORMATICS SUPPORT

国家癌症研究所癌症预防部门(NCI DCP)开展并支持研究，以确定一个人患癌症的风险，并找到降低该风险的方法。NCI DCP管理着一系列科学和临床活动，包括确定和开发具有潜在癌症预防活性的化学预防药物和干预措施，进行临床前研究，进行测试试剂和干预措施的第一阶段和第二阶段试验，以及将有希望的药物和干预措施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，都是安全和按规程进行的。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审计和监控，包括验证临床试验数据以及研究人员对方案、良好临床实践指南、适用的法规要求和临床试验政策的遵从性。癌症预防临床试验审计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) conducts and supports research to determine a person's risk of developing cancer and to find ways to reduce that risk. NCI DCP manages a portfolio of scientific and clinical activities that includes identifying and developing chemopreventive agents and interventions with potential cancer prevention activity, performing pre-clinical studies, conducting Phase I and Phase II trials for testing agents and interventions, and moving promising agents and interventions into larger Phase III cancer prevention clinical trials. These cancer prevention trials are conducted by extramural investigators at national and international clinical sites. As a 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 auditing and 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, applicable regulatory requirements and clinical trials policies. The Cancer Prevention Clinical Trials Auditing 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.