Chemoprevention Clinical Trial of Pomegranate Fruit Extract in Men

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，以快速评估癌症预防剂的临床活性和生物学效应。研究的药剂包括由制药业开发并提供给DCP合作开发的药剂、市售药剂和DCP开发的药剂。该计划要求建立一个稳定的临床试验基础设施，以支持大约75个或更多的受试者进行0-II期临床试验，主要侧重于II期试验。将在不同复杂程度的多器官系统中进行试验。临床试验将在承包商的机构或一个或多个合作机构进行，以提高承包商进行这些试验的能力。承包商将负责所有研究的监督，包括对累积机构的患者层面监测。

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.