Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10544837
• 负责人: Andrew J Armstrong
• 金额: $ 14.09万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-01-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10544837
• 关键词: Advocate; Affect; Amendment; Authorization documentation; Cancer Center Support Grant; Cancer Patient; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Committee Membership; Communities; Community Health Education; Diagnostic; Disease; Doctor of Philosophy; Education; Enrollment; Ensure; Intervention; Malignant Neoplasms; Monitor; Patient Care; Patients; Peer Review; Pharmacists; Preventive; Process; Prospective Studies; Protocols documentation; Research; Research Design; Research Personnel; Research Priority; Resources; Review Committee; Scientist; System; Tissues; Voting; Work; anticancer research; authority; cancer care; falls; improved; meetings; member; multidisciplinary; programs; tool

ABSTRACT – PROTOCOL REVIEW AND MONITORING SYSTEM Duke Cancer Institute’s Protocol Review and Monitoring System (PRMS) falls within the scope of responsibility of the Cancer Protocol Committee (CPC). The CPC is responsible for implementation of the PRMS function, including evaluating the scientific merit and progress of all studies that meet the DCI definition of “cancer-related”. While the CPC upholds standards in scientific rigor and integrity during the protocol review process, it also helps investigators and study teams attain such standards by providing essential resources and education. By meeting its scientific oversight responsibilities, the CPC ensures that DCI investigators conduct high quality and impactful clinical research that aligns with the DCI’s research priorities and meets the needs of the cancer patient community. In addition, the CPC works closely with the clinical Disease Groups and DCI CCSG Research Programs in the prioritization of clinical trials for review. The CPC is a scientific peer-review committee comprised of 40 voting members that reflect the multidisciplinary clinical research enterprise at the DCI. The CPC membership is selected to ensure diverse expertise relevant to cancer clinical research and is composed of clinical investigators, investigational pharmacists, biostatisticians, translational PhD scientists, and patient advocates. All cancer-related protocols are approved by the CPC prior to activation and approved studies that remain open to enrollment must undergo continuing review by the CPC every six months from study activation. Studies reviewed include interventional (treatment, preventive, supportive, diagnostic) and non-interventional (ancillary, correlative [tissue-based], observational) studies. In addition, amendments to cancer-related studies are prospectively assessed and reviewed by the CPC. The CPC approves well-designed studies that hold the potential to positively affect cancer care and has the authority to terminate studies that fail to demonstrate meaningful progress or lose relevance due to shifting paradigms of cancer research and cancer patient care. During the past project period, CPC reviewed a total of 1,316 new protocols, 918 annual renewals, and 322 amendments.

摘要 – 方案审查和监测系统 杜克癌症研究所的方案审查和监测系统 (PRMS) 属于以下范围： 癌症方案委员会 (CPC) 的职责。 CPC负责实施PRMS 功能，包括评估所有符合 DCI 定义的研究的科学价值和进展 “与癌症有关”。 CPC在方案审查过程中坚持科学严谨和诚信的标准 过程中，它还通过提供必要的资源和帮助研究人员和研究团队达到这些标准 教育。通过履行其科学监督职责，CPC 确保 DCI 调查人员进行 高质量和有影响力的临床研究，符合 DCI 的研究重点并满足 癌症患者社区。此外，CPC 与临床疾病组和 DCI 密切合作 CCSG 研究计划对临床试验进行优先审查。 CPC 是一个科学同行评审委员会，由 40 名投票成员组成，反映了 DCI 的多学科临床研究企业。中共党员的选拔要保证多元化 与癌症临床研究相关的专业知识，由临床研究人员、研究人员组成 药剂师、生物统计学家、转化型博士科学家和患者权益倡导者。所有癌症相关方案 在激活之前获得 CPC 的批准，并且仍开放注册的批准研究必须经过 自研究启动后，CPC 每六个月继续进行一次审查。审查的研究包括介入 （治疗、预防、支持、诊断）和非干预（辅助、相关[基于组织]、 观察）研究。此外，对癌症相关研究的修订进行了前瞻性评估和 经中国共产党审查。 CPC 批准精心设计的研究，这些研究有可能对癌症治疗产生积极影响，并具有 有权终止未能证明有意义的进展或因转移而失去相关性的研究 癌症研究和癌症患者护理的范例。在过去的项目期间，CPC 共审查了 1,316 项新协议、918 项年度更新和 322 项修订。