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: 9566071
• 负责人: CAROLINE C SIGMAN
• 金额: $ 209.55万
• 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 2018-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9566071
• 关键词: Area; Bioinformatics; Chemistry; Chemopreventive Agent; Clinic; Clinical Trials; Contracts; Data; Decision Making; Development; Division of Cancer Prevention; Documentation; Formulation; Government Agencies; Human Resources; Information Management; Malignant Neoplasms; Management Information Systems; Medical center; Molecular Models; Monitoring Clinical Trials; 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; clinical development; molecular modeling; multidisciplinary; neoplasm resource; preclinical development; 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.

癌症预防剂预防剂（DCP）的国家癌症研究所要求延续技术信息支持癌症预防剂鉴定，开发和临床试验资格的资源。满足RFP Workscope所需的项目应提供DCP最有希望的癌症化学预防剂的临床前和临床开发所需的潜水技术支持服务。技术支持包括代理背景，基本原理，化学和测试文件，用于决策和规划DCP代理发展委员会的临床开发策略；由化学预防剂开发研究小组和其他DCP研究小组；通过预防癌症计划；通过与DCP合同下的法规支持，临床试验监测以及存储库的获取，配方和分配人员。进行临床前研究和临床试验的研究人员将在适当的情况下进行这种支持；由DCP计划人员进行分析和计划； NCI计划审查委员会由NC​​I科学顾问委员会的建议建立；以及其他NCI员工，其他政府机构的官员以及其他科学家（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）。 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, continuously 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.此外，与代理识别，优化，开发和临床测试资格有关的“ - 运动”技术，分子建模和生物信息学的进步正在增加信息管理要求，以便做出知情的决策和战略计划。该合同支持DCP明确定义和集成的计划，以开发从发现到诊所的化学预防代理。