Protocol Review and Monitoring System

议定书审查和监测系统：摘要 佛罗里达大学健康癌症中心(UFHCC)协议审查和监测系统(PRMS)是 负责所有与癌症相关的临床研究的科学评估、优先排序和监测 由UFCC进行。PRMS的总体目标是确保临床研究组合包括 具有影响力和科学依据的研究与UFCC的战略愿景相一致。所有PRMS活动都是 由UFHCC临床研究办公室协调。UFCC使用由疾病部位组成的两阶段流程 工作组(DSG)和科学审查和监测委员会(SRMC)进行审查。DSG提供了一个 综合、多学科方法，指导选择和认可高质量的癌症临床 试验，而SRMC审查研究的科学价值，包括研究设计，方法， 统计分析计划、应计目标预期、确保参与者安全的程序和机构 优先考虑。对所有干预性研究进行可行性评估，以确认有足够的数量 潜在参与者和充足的临床资源。为了促进使命协调，佛罗里达大学 要求所有与癌症相关的研究方案必须在以下时间之前由国家癌症研究委员会审查和批准 机构审查委员会(IRB)的批准。在SRMC提交之前，所有干预性试验都由 对于科学和临床的兴趣和与UFCC集水区相关的适当的DSG。后者 由社区外联和参与办公室主任核实，他是 SRMC。SRMC侧重于科学价值和研究进展，其职能与此并不重叠 IRB，其管辖权主要是参与者的安全。SRMC优先考虑竞争UFHCC的试验 资源或参与者，并拥有批准/终止研究的最终权力，不得上诉。SRMC 对所有积极的介入临床试验进行持续的审查，以确保它们做出了足够的科学研究 进步。SRMC关闭对以下行为的审判：收益不足、丧失科学功绩或违反协议 损害参与者的安全或研究的科学完整性。SRMC成员是多学科的，以确保 对拟议的癌症临床研究进行公平、批判性的审查。成员包括具有以下专业知识的教职员工 临床调查、生物统计学、研究药学、临床护理、护理、实验室、生物行为和 人口科学和公民科学家。在2021年，DSG考虑了238项新的临床研究， 最终向国资委提出86项(36%)，其中53项获得批准，29项有规定地获得批准，以及 4个被提交。没有一项不获批准，主要是因为DSG审查程序严格。2021年，国家发改委还 完成66项议定书修正案审查和131项续展审查。续展审查的结果是 76个批准，34个试用批准，21个终止合同。大多数试用期批准与以下内容有关 新冠肺炎大流行带来的招生挑战。未来的方向包括缩短时间表 用于SRMC审批、无纸化文件和优化集水区影响。

PROTOCOL REVIEW AND MONITORING SYSTEM: ABSTRACT The University of Florida Health Cancer Center (UFHCC) Protocol Review and Monitoring System (PRMS) is responsible for scientific evaluation, prioritization, and monitoring of all cancer-relevant clinical research conducted by the UFHCC. The overall goal of the PRMS is to ensure that the clinical research portfolio consists of impactful and scientifically sound studies aligned with the UFHCC strategic vision. All PRMS activities are coordinated by the UFHCC Clinical Research Office. UFHCC uses a 2-stage process consisting of Disease Site Group (DSG) and Scientific Review and Monitoring Committee (SRMC) reviews. The DSGs provide an integrated, multidisciplinary approach to guide the selection and endorsement of high-quality cancer clinical trials, while the SRMC reviews research studies for scientific merit, including study design, methodology, statistical analysis plan, accrual goal expectations, procedures to ensure participant safety, and institutional priority. A feasibility assessment is performed for all interventional studies to confirm there are a sufficient number of potential participants and adequate clinical resources. To facilitate mission alignment, the University of Florida mandates that all cancer-relevant research protocols must be reviewed and approved by the SRMC prior to Institutional Review Board (IRB) approval. Prior to SRMC submission, all interventional trials are reviewed by the appropriate DSG for scientific and clinical interest and relevance to the UFHCC catchment area. The latter is verified by the Director of the Office of Community Outreach and Engagement, who serves as a member of the SRMC. The SRMC focuses on scientific merit and study progress, and its function does not overlap with that of the IRB, whose jurisdiction is primarily participant safety. SRMC prioritizes trials competing for UFHCC resources or participants and has final authority on study approval/termination, without appeal. The SRMC conducts ongoing reviews of all active interventional clinical trials to ensure they are making sufficient scientific progress. The SRMC closes trials for inadequate accrual, loss of scientific merit, or protocol violations that compromise participant safety or the scientific integrity of a study. SRMC members are multidisciplinary to ensure a fair, critical review of proposed cancer clinical studies. Membership includes faculty and staff with expertise in clinical investigation, biostatistics, research pharmacy, clinical care, nursing, laboratory, biobehavioral and population science, and Citizen Scientists. In 2021, DSGs considered 238 new clinical research studies, ultimately bringing 86 (36%) to the SRMC, of which 53 were approved, 29 were approved with stipulations, and 4 were tabled. None were disapproved, due largely to rigor of the DSG review process. In 2021, the SRMC also completed 66 protocol amendment reviews and 131 continuation reviews. The continuation reviews resulted in 76 approvals, 34 probationary approvals, and 21 terminations. Most probationary approvals were related to challenges with enrollment resulting from the COVID-19 pandemic. Future directions include shortening timelines for SRMC approval, paperless documentation, and optimization of catchment area impact.