CANCER PREVENTION CLINICAL TRIALS AUDITING AND INFORMATICS SUPPORT

癌症预防临床试验审核和信息学支持

基本信息

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
项目类别：
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

项目摘要

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.

美国国家癌症研究所癌症预防部门 (NCI DCP) 开展并支持癌症预防、早期检测和筛查以及癌症患者症状和毒性的预防和管理方面的研究。作为一个校外部门，DCP 支持并促进国内外癌症科学关键领域的研究人员的发展。 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药物和干预措施、进行临床前研究、进行测试药物和干预措施的 0/I/II 期试验以及转移有前景的药物和干预措施。干预更大规模的 III 期癌症预防临床试验。这些癌症预防试验是由国家和国际临床中心的校外研究人员进行的。作为试验的赞助商，NCI DCP 负责确保临床试验按照方案安全进行，从最初的安全性研究到新药或干预措施在预防特定类型癌症中的作用的明确评估。履行这一责任需要对临床试验的整个过程进行仔细、彻底的审核和监控，包括验证临床试验数据以及研究者和研究中心对方案、良好临床实践指南、适用的监管要求和临床试验政策的遵守情况。癌症预防临床试验审核和信息学支持合同为 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。