CANCER PREVENTION AGENT DEVELOPMENT PROGRAM: EARLY PHASE CLINICAL RESEARCH

美国国家癌症研究所（NCI）癌症预防部（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感兴趣的癌症预防剂的临床活性和生物学效应。待研究的制剂应包括由制药行业开发并提供给DCP进行合作开发的制剂、市售制剂和DCP开发的制剂。本任务指令的目的是提供支持临床试验开展的核心基础设施。 承包商应对DCP申办的药物进行早期临床试验（0期、I期和II期），评价这些药物对其分子靶点的生物学效应，评价其他相关生物学效应，并确定临床相关结局/相关因素。本任务指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.维护基础设施，以开展和完成早期化学预防临床试验。 B）按照DCP批准计划中确立的指南，根据DCP批准的要求修订数据和安全性监查计划以及多机构监查计划，以支持NCI临床试验的开展。参见http://prevention.cancer.gov/clinicaltrials/management/consortia。c）作为DCP、NCI和进行单独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表现。e）提供数据管理以支持试验的进行。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订单提供资金。

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.