CANCER PREVENTION CLINICAL TRIALS AUDITING AND INFORMATICS SUPPORT

癌症预防临床试验审核和信息学支持

• 批准号: 10074446
• 负责人: DAVID MALLOY
• 金额: $ 256.84万
• 依托单位: TECHNICAL RESOURCES INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-16 至 2020-05-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10074446
• 关键词: Area; Cancer Patient; Cancer Prevention Trial; Cancer Science; Chemopreventive Agent; Clinical; Clinical Practice Guideline; Clinical Trials; Collection; Conduct Clinical Trials; Contractor; Contracts; Country; Data; Division of Cancer Prevention; Documentation; Early Diagnosis; Ensure; Evaluation; Extramural Activities; Good Clinical Practice; Informatics; Information Systems; International; Intervention; Monitor; National Cancer Institute; New Agents; Pharmacy facility; Phase; Policies; Prevention; Procedures; Process; Protocols documentation; Reporting; Research Personnel; Research Support; Role; Services; Site; Support Contracts; Testing; Toxic effect; Training and Education; Work; cancer prevention; cancer type; clinical research site; data archive; data management; early screening; preclinical study; prevention clinical trial; programs; repository; safety study; symptom management

The National Cancer Institute Division of Cancer Prevention (NCI DCP) conducts and supports research in cancer prevention, early detection and screening, and on the prevention and management of symptoms and toxicities in cancer patients. As an extramural division, DCP supports and promotes investigators around the country and internationally in these critical areas of cancer science. NCI DCP manages a portfolio of scientific and clinical activities that includes identifying and developing chemopreventive agents and interventions with potential cancer prevention activity, performing pre-clinical studies, conducting Phase 0/I/II trials for testing agents and interventions, and moving promising agents and interventions into larger Phase III cancer prevention clinical trials. These cancer prevention trials are conducted by extramural investigators at national and international clinical sites. As a sponsor of a trial, NCI DCP is responsible for ensuring that clinical trials are conducted safely and according to protocol, from the initial safety studies through the definitive evaluation of the role of the new agent or intervention in the prevention of specific types of cancer. Fulfillment of this responsibility requires careful and thorough auditing and monitoring of a clinical trial throughout its entire process including the verification of clinical trials data as well as investigator and study site compliance with the protocol, Good Clinical Practice Guidelines, applicable regulatory requirements and clinical trials policies. The Cancer Prevention Clinical Trials Auditing and Informatics Support contract provides comprehensive clinical trial oversight capability for the Phase 0/I/II and selected Phase III cancer prevention clinical trials sponsored by NCI DCP.

国家癌症研究所癌症预防部（NCI DCP）开展并支持癌症预防，早期发现和筛查以及癌症患者症状和毒性的预防和管理研究。作为一个校外部门，DCP支持和促进全国各地和国际上在癌症科学的这些关键领域的研究人员。 NCI DCP管理一系列科学和临床活动，包括识别和开发具有潜在癌症预防活性的化学预防剂和干预措施，进行临床前研究，进行0/I/II期试验以测试药物和干预措施，并将有前途的药物和干预措施转移到更大的III期癌症预防临床试验中。这些癌症预防试验由国家和国际临床研究中心的校外研究人员进行。作为试验的申办者，NCI DCP负责确保临床试验安全地按照方案进行，从最初的安全性研究到对新药或干预措施在预防特定类型癌症中的作用的最终评估。履行这一责任需要在整个过程中对临床试验进行仔细和彻底的稽查和监查，包括验证临床试验数据以及研究者和研究中心是否符合方案、药物临床试验质量管理规范指南、适用的法规要求和临床试验政策。癌症预防临床试验审核和信息支持合同为NCI DCP赞助的0/I/II期和选定的III期癌症预防临床试验提供全面的临床试验监督能力。