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: 10431751
• 负责人: PAUL LIMBURG
• 金额: $ 51.26万
• 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 2022-09-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10431751
• 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效果。拟研究的药剂应包括制药行业开发并提供给DCP用于协作开发的药剂、商业上可用的药剂和DCP开发的药剂。本任务单的目标是提供核心基础设施，以支持临床试验的进行。 承包商应进行DCP发起的药物的早期临床试验(0期、I期和II期)，评估这些药物对其分子靶标的生物效应，评估其他相关的生物效应，并确定临床相关的结果/相关性。该任务令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)根据DCP批准计划中建立的指导方针，根据DCP批准计划的要求修订数据和安全监测计划和多机构监测计划计划，以支持NCI临床试验的进行。请参阅http://prevention.cancer.gov/clinicaltrials/management/consortia.C)担任DCP、NCI和进行个别临床试验的分包商之间的联络人。D)通过远程和现场监测访问，监测个别研究的执行情况。E)提供数据管理，以支持审判工作。F)参加年度会议--即科学和I-SCORE个人临床试验--应根据单独的任务单提供资金。