TECHNICAL INFORMATION RESEARCH RESOURCES FOR CANCER PREVENTIVE AGENT DEVELOPMENT

癌症预防剂开发的技术信息研究资源

• 批准号: 8930898
• 负责人: CAROLINE C SIGMAN
• 金额: $ 193.02万
• 依托单位: CCS ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-30 至 2015-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8930898
• 关键词: Area; Bioinformatics; Chemistry; Chemopreventive Agent; Clinic; Clinical; Clinical Trials; Contracts; Data Analyses; Decision Making; Development; Division of Cancer Prevention; Documentation; Drug Formulations; Government Agencies; Human Resources; Information Management; Malignant Neoplasms; Management Information Systems; Medical center; Molecular Models; Monitoring Clinical Trials; NCI Board of Scientific Advisors; National Cancer Institute; Pharmacologic Substance; Prevention Research; Prevention program; Preventive; Private Sector; Program Reviews; Qualifying; Recommendation; Reporting; Research Contracts; Research Institute; Research Personnel; Resources; Review Committee; Scientist; Senior Scientist; Services; Site; Strategic Planning; Support Contracts; Technology; Testing; Universities; Writing; molecular modeling; multidisciplinary; neoplasm resource; pre-clinical; preclinical evaluation; preclinical study; programs; repository; research and development; research clinical testing

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.

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工作范围所需的项目应提供DCP临床前和临床开发最有前途的癌症化学预防剂所需的各种技术支持服务。技术支持包括DCP制剂开发委员会、化学预防制剂开发研究组和其他DCP研究组、PREVENT癌症计划、监管支持、临床试验监测以及与DCP签订合同的储存库获取、配制和分销人员在决策和规划临床开发策略时使用的制剂背景、原理、化学和检测文件。这种支持将酌情扩大，由进行临床前研究和临床试验的研究者;由DCP项目工作人员进行分析和规划;由根据NCI科学顾问委员会的建议建立的NCI项目审查委员会;以及由其他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站点等）。需要复杂，全面和多学科的技术资源，因为目前DCP高级科学家每年审查和优先考虑许多候选药物进行初始临床前评价，在临床开发轨道上的里程碑决策点持续评价数十种药物，以进一步开发，目的是使IND和早期临床试验的药物合格，并监督一系列潜在癌症预防药物的高级临床试验。此外，“组学”技术，分子建模和生物信息学相关的代理识别，优化，开发和资格的临床试验的进步正在增加信息管理的要求，以便作出明智的决定和战略规划。该合同支持DCP明确定义和综合计划，用于开发从发现到临床的化学预防剂。