Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10625764
• 负责人: Ryan M. Thomas
• 金额: $ 5.57万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10625764
• 关键词: Abbreviations; Achievement; Amendment; Appropriateness Review; Authorization documentation; Biometry; COVID-19 pandemic; Cancer Center; Cancer Center Support Grant; Cancer Control; Catchment Area; Classification; Clinical; Clinical Cancer Center; Clinical Data; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials; Clinical Trials Network; Committee Members; Committee Membership; Community Outreach; Data; Devices; Discipline of Nursing; Disease; Documentation; Early Therapeutic-Clinical Trials Network; Enrollment; Ensure; Faculty; Florida; Future; Goals; Health; Health Services Research; Immune response; Institution; Institutional Review Boards; Intervention; Intervention Studies; Intervention Trial; Investigational Drugs; Investigational Therapies; Laboratories; Last Name; Malignant Neoplasms; Methodology; Mission; Monitor; National Clinical Trials Network; Participant; Peer Review; Pharmacy facility; Population Sciences; Principal Investigator; Procedures; Process; Protocols documentation; Qualifying; Research; Research Design; Resources; Review Committee; Risk; Safety; Science; Scientific Evaluation; Site; Statistical Data Interpretation; Strategic vision; Structure; System; Text; Universities; anticancer research; authority; biobehavior; cancer clinical trial; citizen science; clinical care; clinical investigation; clinical practice; clinically relevant; community engagement; data integrity; data management; expectation; interdisciplinary approach; interest; investigator-initiated trial; member; multidisciplinary; participant safety; programs; protocol violation; recruit; research study; sound; timeline; treatment response; tumorigenesis

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.

协议审查和监视系统：摘要 佛罗里达大学健康癌症中心（UFHCC）协议审查与监测系统（PRMS）是 负责对所有与癌症相关的临床研究的科学评估，优先级和监测 由UFHCC进行。 PRM的总体目标是确保临床研究组合组成 有影响力和科学的声音研究与UFHCC的战略愿景保持一致。所有PRM的活动都是 由UFHCC临床研究办公室协调。 UFHCC使用由疾病部位组成的2阶段过程 小组（DSG）和科学审查与监测委员会（SRMC）评论。 DSG提供了 指导高质量癌症的选择和认可的综合多学科方法 试验，而SRMC回顾了科学功绩的研究，包括研究设计，方法论， 统计分析计划，应计目标期望，确保参与者安全的程序和机构 优先事项。对所有介入研究进行了可行性评估，以确认有足够的数量 潜在参与者和足够的临床资源。为了促进佛罗里达大学的任务对齐 要求在SRMC之前对所有与癌症有关的研究方案进行审查和批准 机构审查委员会（IRB）批准。在提交SRMC之前，所有介入试验均由 适当的DSG，可用于科学和临床兴趣以及与UFHCC集水区的相关性。后者 由社区外展与参与办公室主任进行了验证，他担任成员 SRMC。 SRMC专注于科学的优点和研究进步，其功能并没有重叠 IRB的管辖权主要是参与者的安全。 SRMC优先考虑与UFHCC竞争的试验 资源或参与者，没有上诉的最终授权/终止研究批准/终止。 SRMC 对所有主动介入的临床试验进行持续的审查，以确保它们具有足够的科学性 进步。 SRMC关闭了应计的不足，科学价值丧失或违反议定书的试验 妥协参与者的安全或研究的科学完整性。 SRMC成员是多学科的 对拟议的癌症临床研究的公平，批判性的审查。会员包括具有专业知识的教职员工 临床研究，生物统计学，研究药房，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，DSGS考虑了238项新的临床研究， 最终将86（36％）带到SRMC，其中53名获得了批准，有29名获得了规定，并获得了规定的批准 4个被列出。没有人被拒绝，这在很大程度上是由于DSG审查过程的严格性。在2021年，SRMC也 完成了66项协议修正案审查和131次延续评论。连续评论导致 76个批准，34个试用批准和21个终止。大多数试用批准与 COVID-19大流行带来的入学率挑战。未来的指示包括缩短时间表 用于SRMC批准，无纸文档以及集水区影响的优化。