Protocol Review and Monitoring System

项目摘要/摘要 议定书审查和监测系统(PRMS)为所有人类提供严格的科学审查 受试者在该机构内进行癌症临床研究，包括附属网站。PRMS负责 审查每个研究方案的科学价值、生物统计设计、应计估计、 西德尼·基梅尔综合癌症中心(SKCCC)专注于疾病/模式的临床研究小组 (CRGs)和SKCCC，并随着时间的推移而取得进展。PRMS通过两个阶段的审查完成其收费 进程。第一阶段包括由CRG对每个试验概念进行初步审查和确定优先次序。它是遵循的 经代表中心的PRMS临床研究委员会(PRMS-CRC)的一个小组委员会审查- 广泛共享资源，对可行性进行评估并提供反馈，并确定需要关注的领域 由研究小组在第二阶段审查之前提出。CRG是一个多学科的组织， 调查人员和研究人员，由指定的教职员工领导，并由中心支持的CRG协助 经理们。CRG跟踪未按优先顺序继续进行的研究和进行到第二步的研究 舞台。CRGs内审查的标准包括科学优先级、临床需求、方案领导力、 集水区和资金来源。PRMS审查的第二阶段包括科学和生物统计学 由PRMS-CRC审查所有与癌症相关的临床试验方案。PRMS-CRC接收CRG输入 关于新的和现有的议定书的适当优先次序。临立会--儿童权利委员会成员任期两年，可连任 并由SKCCC主任任命。它们反映了科学研究计划和CRG在 中心由生物统计学、病理学、转化实验室、患者倡导和人口/代表组成 行为科学。该委员会有权批准机构审查委员会的审查方案 符合SKCCC的科学价值和优先事项，并关闭尚未证明的议定书 充分的科学进步。PRMS-CRC有一名专门的PRMS管理员。与临床医生合作 协议和数据管理办公室，监测和改进协议激活时间表的举措 在2020年将激活时间的中位数减少到111天。有持续的努力来保持对 在临床研究中纳入妇女、少数民族和整个生命周期的个人的重要性。这些 在少数群体包容方面，努力是可操作和有效的，始终与少数群体代表性保持一致 在SKCCC看到的。在2020财年CRGs分类的283项研究中，111项干预性试验 优先向前推进。在83项需要进行全面审查的项目中，19项获得书面批准，34项获得批准。 其中23项微小修改需要重新审查，7项重大修改需要重新审查。 对134项试验进行了年度科学审查。2020年，79项研究因各种原因关闭：66% 按计划完成，13%因低收益或竞争性研究而关闭，12%因 在可行性问题上，5%的人因缺乏疗效而关闭，4%的人不再具有科学意义。

PROJECT SUMMARY/ABSTRACT The Protocol Review and Monitoring System (PRMS) provides rigorous scientific review of all human subjects cancer clinical research within the institution, including affiliate sites. The PRMS is responsible for reviewing each research protocol for scientific merit, biostatistical design, accrual estimates, priority within the Sidney Kimmel Comprehensive Cancer Center (SKCCC) disease-/modality-focused Clinical Research Groups (CRGs) and SKCCC, and progress over time. The PRMS accomplishes its charge through a two-stage review process. The first stage includes initial review and prioritization of each trial concept by the CRGs. It is followed by review by a sub-committee of the PRMS Clinical Research Committee (PRMS-CRC), representing Center- wide Shared Resources, to evaluate and provide feedback on feasibility and identify areas of concern to be addressed by the study team before the second stage of review. CRGs are multidisciplinary groups of investigators and research staff, led by designated faculty leaders and assisted by Center-supported CRG Managers. CRGs track studies that are not prioritized to move further and those that move to the second stage. Criteria for review within CRGs include scientific priority, clinical need, protocol leadership, needs of the catchment area and funding source. The second stage of PRMS review includes the scientific and biostatistical review of every cancer-related clinical trial protocol by the PRMS-CRC. The PRMS-CRC receives CRG input on proper prioritization of new and existing protocols. PRMS-CRC Members serve two-year, renewable terms and are appointed by the SKCCC Director. They reflect the scientific Research Programs and CRGs in the Center with representation from biostatistics, pathology, translational labs, patient advocacy and population/ behavioral science. The committee has the authority to approve protocols for Institutional Review Board review that meet the scientific merit and priorities of the SKCCC, and to close protocols that have not demonstrated adequate scientific progress. The PRMS-CRC has a dedicated PRMS Manager. Working with the Clinical Protocol and Data Management Office, initiatives to monitor and improve protocol activation timelines largely reduced the median activation time to 111 days in 2020. There are ongoing efforts to maintain awareness of the importance of inclusion of women, minorities and individuals across the life span in clinical research. These efforts are operational and effective with minority inclusion, consistently aligning with minority representation seen at the SKCCC. Of the 283 studies triaged by CRGs during CY2020, 111 interventional trials were prioritized to move forward. Of the 83 requiring full PRMS-CRC review, 19 were approved as written, 34 were approved with minor clarifications, 23 required re-review for minor modifications and seven for major revisions. Annual scientific reviews were conducted on 134 trials. In 2020, 79 studies closed for various reasons: 66% were completed as planned, 13% were closed for low accrual or competing studies, 12% were closed for issues of feasibility, 5% were closed due to lack of efficacy and 4% were no longer scientifically relevant.