Protocol Review and Monitoring Committee

摩尔癌症中心(MCC)方案审查和监测系统(PRMS)监督和提供 对所有癌症研究的科学价值、优先顺序和进展进行独立的同行评审 在加州大学圣地亚哥分校，其附属机构Rady进行了人体实验 儿童医院以及MCC进行的与癌症相关的人口科学研究 联盟合作伙伴，圣地亚哥州立大学。PRMS功能通过以下方式实现 严格审查分两个阶段进行，由以下人员进行： 1)MCC多学科疾病团队，其中对价值、适合性和 在现有的研究范围内确定优先顺序，并进行评估 每项研究的业务可行性和应计可行性；和2)议定书审查和监测 委员会(PRMC)，这是决定哪些研究的最终独立机构 继续进行激活。需要疾病小组的投入和批准才能 向革命制度委员会提起诉讼；然而，只有革命制度委员会对以下事项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。这个 PRMC的主要目标是确保所有MCC对齐的癌症研究涉及人类 主题是：1)科学合理；2)有效设计，特别是根据生物统计学 观点；3)在MCC疾病团队的研究组合中适当区分优先顺序，以避免 相互竞争的试验，并与MCC的临床总体机构优先事项保持一致 研究；4)完成或达到机构应计目标的可行性；5)评估 基于研究的风险水平的数据和安全监测计划的充分性；以及6) 定期监测成果和科学进展情况。2017年，MCC疾病小组已经审查了 总共有198项研究，并将其中165项研究提交给PRMC审查。一旦由 PRMC，其中46项研究得到了PRMC主席、副主席或 被指定者，因为他们已经接受了适当的外部科学同行审查，119 这些研究中，主要代表MCC的研究人员发起和行业赞助 试验，被转交给PRMC进行全面审查。超过22%的研究由临管会审阅 在获得批准之前需要修改，3项研究不被批准和不允许 继续执行激活过程。此外，PRMC还进行了科学和应计 对所有积极积累的MCC研究的进展进行审查，其中24项研究表现不佳 于2017年关闭。MCC PRMS包括疾病小组和PRMC审查过程，是以下之一 MCC为确保最高质量的研究所执行的最关键职能是 正在MCC进行。

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.