CORE INFRASTRUCTURE SUPPORT FOR THE CANCER PREVENTION AGENT DEVELOPMENT PROGRAM

癌症预防剂开发计划的核心基础设施支持

• 批准号: 10249930
• 负责人: PAUL LIMBURG
• 金额: $ 80.77万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-23 至 2021-09-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10249930
• 关键词: Biological; Clinical; Clinical Chemoprevention; 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/clinicaltrials/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.

美国国家癌症研究所 (NCI) 癌症预防部门 (DCP) 0/I/II 期癌症预防临床试验计划支持早期临床试验，以快速评估 DCP 感兴趣的癌症预防药物的临床活性和生物学效应。研究应包括由制药行业开发并提供给 DCP 进行协作开发的药物、市售药物以及由 DCP 开发的药物。本任务指令的目标是提供核心基础设施来支持临床试验的进行。 承包商应对 DCP 赞助的药物进行早期临床试验（第 0、I 和 II 期），评估这些药物对其分子靶标的生物效应，评估其他相关生物效应，并确定本任务订单的临床相关结果/相关性。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： a. 维护进行和完成早期化学预防临床试验的基础设施 b) 修订数据和安全监测计划。和根据 DCP 批准计划制定多机构监测计划，以支持 NCI 临床试验的进行。 ) 充当 DCP、NCI 和执行个体临床试验的分包商之间的联络人 d) 远程和现场监测访问监控个体研究的表现 e) 提供数据管理以支持试验。 f) 参加年度会​​议——即科学和 I-SCORE 个人临床试验应根据单独的任务指令获得资助。