Contract HHSN261201200042I, 09/24/2012 - 09/23/2017Cancer Prevention Agent Development Program: Early Phase Clinical ResearchTask Order HHSN26100008, 09/24/2014 - 09/23/2015Core Infrastructure

合同 HHSN261201200042I, 09/24/2012 - 09/23/2017癌症预防剂开发计划：早期临床研究任务订单 HHSN26100008, 09/24/2014 - 09/23/2015核心基础设施

• 批准号: 8947473
• 负责人: PAUL LIMBURG
• 金额: $ 72.4万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-24 至 2015-09-23
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8947473
• 关键词: Apoptosis; Biological; Clinical; Clinical Trials; Contractor; Contracts; Development; Division of Cancer Prevention; Drug Industry; Growth Factor; Institution; Intraepithelial Neoplasia; Laboratories; Malignant Neoplasms; Molecular Target; Monitor; National Cancer Institute; Oncogenes; Organ; Participant; Patients; Phase; Phase II Clinical Trials; Prevention; Preventive; Program Development; Research Infrastructure; Site; Specific qualifier value; body system; cancer prevention; carcinogenesis; clinically relevant; design; insight; novel; prevention clinical trial; programs; response

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. The agents to be studied include agents developed by the pharmaceutical industry and provided to DCP for collaborative development, commercially available agents, and agents developed by DCP. The program requires the establishment of a stable clinical trials infrastructure to support the accrual of approximately 75 or more subjects to phase 0-II clinical trials, with an emphasis primarily on phase II trials. Trials in multiple organ systems and with varying degrees of complexity will be performed. Clinical trials will be performed at the Contractor�s institution or at one or more collaborating institutions which enhance the capability of the Contractor to conduct these trials. The Contractor will be responsible for the oversight of all studies, including patient-level monitoring of accruing institutions.

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，以快速评估癌症预防药物的临床活性和生物学效应。要研究的药物包括。该计划需要建立稳定的临床试验基础设施，以支持约 75 名或更多受试者进入 0-II 期。临床试验，将在承包商的机构或一个或多个合作机构进行不同复杂程度的多器官系统试验，以增强承包商进行这些试验的能力。承包商将负责监督所有研究，包括对累积机构进行患者层面的监测。