OTHER FUNCTIONS - CANCER PREVENTION AGENT DEVELOPMENT PROGRAM: EARLY PHASE CLINICAL RESEARCH

其他功能 - 癌症预防剂开发计划：早期临床研究

• 批准号: 10901815
• 负责人: POWEL BROWN
• 金额: $ 18.32万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 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 2024-09-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10901815
• 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; Institution; 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（DCP）的0/I/II期癌症预防临床试验项目支持早期临床试验，以快速评估DCP感兴趣的癌症预防剂的临床活性和生物学效应。研究的药剂应包括制药行业自行开发并提供给DCP合作开发的药剂、市售药剂和DCP自行开发的药剂。本任务令的目标是提供核心基础设施，以支持临床试验的进行。