Protocol Review and Monitoring Committee

方案审查和监测委员会

• 批准号: 10160807
• 负责人: Ezra Cohen
• 金额: $ 18.3万
• 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/10160807
• 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.

摩尔斯癌症中心 (MCC) 方案审查和监测系统 (PRMS) 负责监督和提供 对所有癌症研究的科学价值、优先事项和进展进行独立的同行评审 涉及人类受试者的研究是在加州大学圣地亚哥分校及其附属机构 Rady 进行的 儿童医院以及中冶开展的癌症相关人口科学研究 联盟合作伙伴，圣地亚哥州立大学。 PRMS 功能是通过以下方式完成的 严格审查分两个阶段进行： 1) MCC 多学科疾病团队，对价值、适合度和 对现有研究组合进行优先排序并进行评估 每项研究的操作和应计可行性； 2) 方案审查和监测 委员会 (PRMC)，它是确定哪些研究的最终独立权威 继续激活。之前需要疾病小组的意见和批准 前往 PRMC；然而，只有 PRMC 拥有最终和独立的权力 确定哪些研究将被启动，哪些表现不佳的研究将被关闭。这 PRMC 的主要目标是确保所有 MCC 一致的涉及人类的癌症研究 主题是：1）科学合理； 2）有效设计，特别是根据生物统计学 看法; 3) 在 MCC 疾病团队的研究组合中适当优先考虑，以避免 竞争性试验以及与 MCC 临床临床机构整体优先事项保持一致 研究; 4) 能够完成或实现机构应计目标； 5) 评估为 基于研究风险水平的数据和安全监测计划的充分性；和 6) 定期监测权责发生制和科学进展。 2017年，MCC疾病小组审查了 总共 198 项研究，并将其中 165 项研究转发给 PRMC 审查。一旦收到 PRMC，其中 46 项研究得到了 PRMC 主席、副主席或 PRMC 指定人员，因为他们已经接受了适当的外部科学同行评审，并且 这些研究主要代表 MCC 的研究者发起和行业赞助 试验，已转交 PRMC 进行全面审查。超过 22% 的研究经过 PRMC 审查 批准前需要修改，3项研究被拒绝且不允许 继续完成激活过程。此外，PRMC还进行了科学的、权责发生制的 对所有积极积累的 MCC 研究进行进度审查，其中 24 项表现不佳的研究 于 2017 年关闭。MCC PRMS（包括疾病团队和 PRMC 审查流程）是其中之一 MCC 为确保最高研究质量而履行的最关键职能是 正在MCC进行。