CANCER PREVENTION CLINICAL TRIALS AUDITING & INFORMATICS SUPPORT

癌症预防临床试验审核

• 批准号: 9262815
• 负责人: DANIEL MOLINA
• 金额: $ 185万
• 依托单位: TECHNICAL RESOURCES INC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-05-30 至 2016-05-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9262815
• 关键词: Cancer Prevention Trial; Chemopreventive Agent; Clinical; Clinical Practice Guideline; Clinical Trials; Conduct Clinical Trials; Contractor; Contracts; Data; Data Reporting; Databases; Division of Cancer Prevention; Documentation; Ensure; Evaluation; Extramural Activities; Good Clinical Practice; Informatics; International; Intervention; Malignant Neoplasms; Monitor; National Cancer Institute; New Agents; Persons; Pharmacy facility; Phase; Phase I/II Trial; Policies; Prevention; Procedures; Process; Protocols documentation; Research Personnel; Research Support; Risk; Role; Services; Site; Support Contracts; Testing; Training and Education; Work; cancer prevention; cancer type; clinical research site; data management; preclinical study; prevention clinical trial; programs; safety study

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.

美国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，并寻找降低该风险的方法。 NCI DCP 管理一系列科学和临床活动，包括识别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 I 期和 II 期试验以测试药物和干预措施，以及转移有前景的药物和干预措施进入更大规模的 III 期癌症预防临床试验。 这些癌症预防试验是由国家和国际临床中心的校外研究人员进行的。 作为试验的赞助商，NCI DCP 负责确保临床试验按照方案安全进行，从最初的安全性研究到新药或干预措施在预防特定类型癌症中的作用的明确评估。 履行这一职责需要对临床试验的整个过程进行仔细、彻底的审核和监控，包括验证临床试验数据以及研究者遵守方案、良好临床实践指南、适用的监管要求和临床试验政策。 癌症预防临床试验审核和信息学支持合同为 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。