Protocol Review and Monitoring System

项目总结/摘要 方案审查和监测系统（PRMS）对所有人类 受试者在机构内进行癌症临床研究，包括附属机构。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、 Sidney Kimmel综合癌症中心（SKCCC）以疾病/模态为中心的临床研究组 （CRG）和SKCCC，并随着时间的推移而发展。PRMS通过两个阶段的审查来完成其任务 过程第一阶段包括CRG对每个试验概念进行初步审查和优先排序。随之而来的 由PRMS临床研究委员会（PRMS-CRC）的一个小组委员会审查，代表中心- 广泛的共享资源，以评估和提供反馈的可行性，并确定关注的领域， 研究小组在第二阶段审查之前处理了这一问题。CRG是多学科的团体， 调查人员和研究人员，由指定的教师领导和中心支持的CRG协助 管理者CRG跟踪那些没有优先级的研究，以进一步移动和那些移动到第二个 阶段CRG内的审查标准包括科学优先级、临床需求、方案领导、 资金来源和资金来源。PRMS审查的第二阶段包括科学和生物统计 PRMS-CRC审查每项癌症相关临床试验方案。PRMS-CRC接收CRG输入 对新的和现有的协议进行适当的优先排序。PRMS-CRC成员任期两年，可连任 并由SKCCC主任委任。它们反映了科学研究计划和CRG， 中心代表来自生物统计学，病理学，翻译实验室，患者倡导和人口/ 行为科学委员会有权批准机构审查委员会审查的方案 符合SKCCC的科学价值和优先事项，并关闭尚未证明的协议 足够的科学进步。PRMS-CRC有一个专门的PRMS经理。与临床合作 方案和数据管理办公室，主要是监测和改进方案启动时间表的举措 将2020年的中位激活时间缩短至111天。目前正在努力保持对下列问题的认识： 在临床研究中纳入妇女、少数民族和个人的重要性。这些 在少数群体参与方面的努力是可操作的和有效的，始终与少数群体的代表性保持一致 在SKCCC看到的。在CY2020期间按CRG分类的283项研究中，111项干预性试验 优先向前推进。在83份需要全面PRMS-CRC审查的申请中，19份以书面形式获得批准，34份以书面形式获得批准， 23项小修改需要重新审查，7项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%因低累积或竞争性研究关闭，12%因 在可行性问题上，5%因缺乏疗效而关闭，4%不再具有科学相关性。

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.