TECHNICAL INFORMATION RESEARCH RESOURCES FOR CANCER PREVENTIVE AGENT DEVELOPMENT

美国国家癌症研究所癌症预防部（DCP）要求继续提供技术信息支持资源，用于癌症预防剂的鉴定、开发和临床试验资格。满足RFP工作范围的项目应为DCP最有前景的癌症化学预防药物的临床前和临床开发提供所需的多种技术支持服务。技术支持包括药物背景、原理、化学和测试文件，用于DCP药物开发委员会的决策和临床开发策略规划；化学预防剂开发研究小组和其他DCP研究小组；预防癌症项目；根据与DCP签订的合同，由监管支持、临床试验监测、储存库获取、配方和分发人员提供。这种支持将酌情由开展临床前研究和临床试验的研究人员扩大；由DCP项目人员进行分析和规划；根据NCI科学顾问委员会的建议成立的NCI项目审查委员会；以及其他NCI工作人员、其他政府机构的官员和其他科学家（例如，大学、研究机构、医疗中心、制药和其他私营部门合作站点等）。目前，DCP的资深科学家每年对许多候选药物进行初步临床前评估，并对其进行优先排序，在临床开发的里程碑决策点持续评估数十种药物，以进一步开发符合ind和早期临床试验资格的药物，因此需要复杂、全面和多学科的技术资源。并监督一系列潜在癌症预防药物的高级临床试验。此外，与药物鉴定、优化、开发和临床试验资格相关的“组学”技术、分子建模和生物信息学的进步正在增加信息管理需求，以便做出明智的决策和战略规划。该合同支持DCP从发现到临床开发化学预防剂的明确定义和综合计划。

The National Cancer Institute, Division of Cancer Prevention (DCP) requires the continuation of technical information support resources for cancer preventive agent identification, development, and qualification for clinical trials. The projects required to satisfy the RFP workscope shall provide the diverse technical support services needed for DCP’s preclinical and clinical development of the most promising cancer chemopreventive agents. Technical support includes agent background, rationale, chemistry, and testing documents for use in decision making and in planning clinical development strategies by the DCP Agent Development Committee; by the Chemopreventive Agent Development Research Group and other DCP Research Groups; by the PREVENT Cancer Program; by regulatory support, clinical trial monitoring, and repository acquisition, formulation, and distribution personnel under contract to the DCP. This support would extend as appropriate, by investigators conducting the preclinical studies and clinical trials; by DCP program staff for analysis and planning; by NCI program review committees established following recommendations of the NCI Board of Scientific Advisors; and by other NCI staff, officials of other government agencies, and other scientists (e.g., at universities, research institutes, medical centers, pharmaceutical and other private sector collaborator sites, etc.). Sophisticated, comprehensive and multidisciplinary technical resources are required because currently the DCP senior scientists scrutinize and prioritize many candidate agents yearly for initial preclinical evaluation, continually evaluate dozens of agents in clinical development tracks at milestone decision points for further development with the objective of qualifying agents for INDs and early clinical trials, and oversee a portfolio of advanced clinical trials of potential cancer preventive agents. Additionally, advances in “-omic” technologies, molecular modeling, and bio-informatics related to agent identification, optimization, development, and qualification for clinical testing are increasing information management requirements in order to make informed decisions and strategic planning. This contract supports DCP’s clearly defined and integrated plan for developing chemopreventive agents from discovery to the clinic.