Protocol Review and Monitoring Committee

方案审查和监测委员会

• 批准号: 10400749
• 负责人: Ezra Cohen
• 金额: $ 18.24万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-07-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10400749
• 关键词: Appointment; Biometry; California; Cancer Center; Cancer Center Support Grant; Clinical Cancer Center; Clinical Research; Cytomegalovirus Infections; Data; Diagnosis; Disease; Ensure; Faculty; Goals; Industry; Institutional Review Boards; Malignant Neoplasms; Medicine; Modification; Monitor; Outcome; Pediatric Hospitals; Peer Review; Population Sciences; Prevention; Procedures; Process; Protocols documentation; Regimen; Research; Research Personnel; Review Committee; Risk; Safety; Screening procedure; Staging; System; Universities; Work; anticancer research; authority; base; cancer research center director; design; expedited review; human subject; improved; meetings; member; multidisciplinary; professor; research study; sound

The Moores Cancer Center (MCC) Protocol Review and Monitoring System (PRMS) oversees and provides independent, peer review of the scientific merit, priority, and progress of all cancer studies involving human subjects conducted at the University of California, San Diego, its affiliated Rady Children's Hospital as well as cancer-related population sciences research conducted at MCC's consortium partner, San Diego State University. PRMS functions are accomplished by rigorous review in a 2-stage process conducted by: 1) MCC multidisciplinary Disease Teams, where initial assessment of value, fit, and prioritization within the existing portfolio of studies is performed as well as an assessment of each study's operational and accrual feasibility; and 2) the Protocol Review and Monitoring Committee (PRMC), which is the definitive independent authority for determining which studies proceed to activation. The Disease Teams' input and approval are required before proceeding to the PRMC; however, only the PRMC has final and independent authority with regards to determining which studies will be activated and which underperforming studies will be closed. The PRMC has the primary goal to ensure that all MCC-aligned cancer research studies involving human subjects are: 1) scientifically sound; 2) effectively designed, specifically from a biostatistics perspective; 3) appropriately prioritized within MCC's Disease Teams' research portfolios to avoid competing trials as well as aligned with MCC's overall institutional priorities for clinical research; 4) feasible for completion or in meeting institutional accrual goals; 5) assessed for the adequacy of the data and safety monitoring plans based on the risk level of the study; and 6) monitored regularly for accrual and scientific progress. In 2017, the MCC Disease Teams have vetted in aggregate 198 studies and forwarded 165 of these studies to PRMC review. Once received by the PRMC, 46 of these studies received an initial expedited review by the PRMC Chair, Vice Chair, or a PRMC designee as they had already received an appropriate external scientific peer-review, and 119 of these studies, primarily representing MCC's investigator-initiated and industry-sponsored trials, were forwarded for full PRMC review. More than 22% of the studies reviewed by the PRMC required modifications prior to being approved, and 3 studies were disapproved and not allowed to proceed through the activation process. In addition, the PRMC also conducted scientific and accrual progress reviews for all actively accruing MCC studies for which 24 underperforming studies were closed in 2017. The MCC PRMS, inclusive of the Disease Team and PRMC review processes, is one of the most critical functions that the MCC performs to ensure the highest quality of research is being conducted at MCC.

Moores癌症中心（MCC）方案审查和监测系统（PRMS）监督并提供 对所有癌症研究的科学价值、优先级和进展进行独立的同行评审 涉及在圣地亚哥加州大学进行的人类受试者，其附属Rady 儿童医院以及在MCC进行的癌症相关人口科学研究 财团合作伙伴，圣地亚哥州立大学。PRMS功能由以下各项完成： 严格审查分两个阶段进行： 1)MCC多学科疾病小组，其中价值，适合， 在现有的研究组合中进行优先排序，并进行评估 每项研究的操作和累积可行性;以及2）方案审查和监测 委员会（PRMC），这是决定哪些研究的权威独立机构 进行激活。疾病小组的意见及批准， 然而，只有PRMC拥有最终和独立的权力， 确定哪些研究将被激活，哪些表现不佳的研究将被关闭。的 PRMC的主要目标是确保所有涉及人类的MCC对齐癌症研究 主题是：1）科学合理; 2）有效设计，特别是从生物统计学 3）在MCC疾病团队的研究组合中适当优先考虑，以避免 竞争性试验，并与MCC的整体机构的临床优先事项保持一致 研究; 4）完成或达到机构应计目标的可行性; 5）评估 基于研究风险水平的数据和安全性监测计划的充分性;以及6） 定期监测应计费用和科学进展。2017年，MCC疾病小组审查了 共198项研究，并将其中165项研究提交PRMC审查。一旦收到 PRMC，其中46项研究接受了PRMC主席、副主席或 PRMC指定人员，因为他们已经收到了适当的外部科学同行评审，以及119 在这些研究中，主要代表MCC的制药商发起和行业赞助 试验，提交给PRMC进行全面审查。PRMC审查的研究中有22%以上 在批准前需要修改，3项研究未获批准，不允许 继续进行激活过程。此外，PRMC还进行了科学和权责发生制 对所有正在进行的MCC研究进行进展审查，其中24项表现不佳的研究 于2017年关闭。MCC PRMS，包括疾病小组和PRMC审查程序，是 MCC为确保最高质量的研究而履行的最关键的职能是 在MCC进行。