TECHNICAL INFORMATION RESEARCH RESOURCES FOR CANCER PREVENTIVE AGENT DEVELOPMENT

国家癌症研究所癌症预防分部(DCP)要求为癌症预防制剂的识别、开发和临床试验资格提供持续的技术信息支持资源。满足RFP工作范围所需的项目应提供DCP临床前和临床开发最有希望的癌症化学预防药物所需的各种技术支持服务。技术支持包括药剂背景、基本原理、化学和测试文件，供DCP药剂开发委员会、化学预防药剂开发研究小组和其他DCP研究小组、预防癌症计划、法规支持、临床试验监测以及与DCP签约的资料库获取、配方和分销人员在决策和规划临床开发策略时使用。这种支持将适当地扩展到：进行临床前研究和临床试验的研究人员；用于分析和规划的DCP计划工作人员；根据NCI科学顾问委员会的建议成立的NCI计划审查委员会；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，在大学、研究机构、医疗中心、制药和其他私营部门合作者网站等)。需要复杂、全面和多学科的技术资源，因为目前DCP的资深科学家每年都会对许多候选药物进行仔细审查和优先排序，进行初步的临床前评估，在具有里程碑意义的决策点持续评估数十种药物，以便进一步开发，目标是使药物符合INDS和早期临床试验的资格，并监督潜在癌症预防药物的一系列高级临床试验。此外，与药物识别、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增加了对信息管理的要求，以便做出明智的决策和战略规划。这份合同支持DCP从发现到临床开发化学预防药物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.