CANCER PREVENTION AGENT DEVELOPMENT PROGRAM: EARLY PHASE CLINICAL RESEARCH

癌症预防剂开发计划：早期临床研究

• 批准号: 10683047
• 负责人: HOWARD BAILEY
• 金额: $ 10.75万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-23 至 2023-09-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10683047
• 关键词: Biological; Clinical; Clinical Chemoprevention; Clinical Research; Clinical Trials; Conduct Clinical Trials; Contractor; Data; Development; Division of Cancer Prevention; Drug Industry; Funding; Guidelines; Individual; Infrastructure; Maintenance; Malignant Neoplasms; Molecular Target; Monitor; National Cancer Institute; Outcome; Performance; Phase; Prevention; Preventive; Program Development; Safety; Site; Visit; cancer prevention; clinically relevant; data management; early phase clinical trial; interest; laboratory experiment; meetings; prevention clinical trial; programs

The National Cancer Institute (NCI), Division of Cancer Prevention (DCP) Phase 0/I/II Cancer Prevention Clinical Trials Program supports early clinical trials to rapidly evaluate the clinical activity and biologic effects of cancer preventive agents of interest to DCP. The agents to be studied shall include agents developed by the pharmaceutical industry and provided to DCP for collaborative development, commercially available agents, and agents developed by DCP. The objectives of this Task Order are to provide the core infrastructure to support the conduct of the clinical trials. The Contractor shall conduct early clinical trials (Phase 0, I, and II) of DCP-sponsored agents, evaluate biologic effects of these agents on their molecular targets, evaluate other relevant biologic effects, and determine clinically relevant outcomes/correlates. This Task Order calls for the maintenance of the administrative core infrastructure to support the clinical and laboratory activities. These activities include but are not limited to: a. Maintaining the infrastructure to conduct and complete Early Phase Chemoprevention Clinical Trials. b) Revising the Data and Safety Monitoring Plan and Multi-Institutional Monitoring Plan plans as required for DCP approval, following guidelines established in the DCP approved plans, in order to support the conduct of NCI clinical trials. See http://prevention.cancer.gov/clinical trials/management/consortia. c) Serving as the liaison between DCP, NCI and sub-contractors performing individual clinical trials. d) Monitoring the performance of individual studies both remotely and via on-site monitoring visits. e) Providing data management to support trial conduct. f) Participating in annual meetings – i.e. Scientific and I-SCORE Individual clinical trials shall be funded under separate Task Orders.

国家癌症研究所（NCI），癌症预防措施（DCP）阶段0/I/II癌症预防临床试验计划支持早期临床试验，以快速评估DCP感兴趣的预防癌症预防剂的临床活性和生物学作用。要研究的代理商应包括制药行业开发的代理商，并向DCP提供合作开发，市售代理商以及由DCP开发的代理商。该任务订单的目标是提供核心基础设施以支持临床试验的行为。 承包商应进行DCP赞助的药物的早期临床试验（0阶段，I和II），评估这些药物对其分子靶标的生物学作用，评估其他相关的生物学效应，并确定与临床相关的结果/相关性。该任务订单要求维护行政核心基础设施，以支持临床和实验室活动。这些活动包括但不限于：维持基础设施以进行和完成早期化学预防临床试验。 b）根据DCP批准的计划中规定的指南，修改DCP批准要求的数据和安全监控计划以及多机构监控计划，以支持NCI临床试验的行为。 c）作为执行单个临床试验的DCP，NCI和分包商之间的联络。 d）远程和通过现场监测访问监测单个研究的表现。 e）提供者数据管理以支持试用行为。 f）参加年度会​​议 - 即科学和I得分个体临床试验应在单独的任务订单下资助。