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.

方案审查和监测系统：摘要 佛罗里达大学健康癌症中心 (UFHCC) 方案审查和监测系统 (PRMS) 负责对所有癌症相关临床研究进行科学评估、优先排序和监测 由 UFHCC 进行。 PRMS 的总体目标是确保临床研究组合包括 与 UFHCC 战略愿景相一致的有影响力且科学合理的研究。所有 PRMS 活动均是 由 UFHCC 临床研究办公室协调。 UFHCC 采用 2 阶段流程，包括疾病部位 小组 (DSG) 和科学审查和监测委员会 (SRMC) 进行审查。 DSG 提供了 综合的、多学科的方法来指导高质量癌症临床的选择和认可 试验，同时 SRMC 审查研究的科学价值，包括研究设计、方法、 统计分析计划、权责发生制目标预期、确保参与者安全的程序以及制度 优先事项。对所有干预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。为了促进任务协调，佛罗里达大学 规定所有与癌症相关的研究方案必须在研究之前经过 SRMC 的审查和批准 机构审查委员会 (IRB) 批准。在 SRMC 提交之前，所有干预试验均由 适合科学和临床兴趣以及与 UFHCC 服务区域相关性的 DSG。后者 由社区外展和参与办公室主任核实，该办公室主任是 SRMC。 SRMC侧重于科学价值和研究进展，其职能与之不重叠 IRB 的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，并对研究批准/终止拥有最终决定权，不得上诉。 SRMC 对所有活跃的介入临床试验进行持续审查，以确保它们做出足够的科学依据 进步。 SRMC 因应计不足、科学价值丧失或违反方案而终止试验 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、严格的审查。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。 2021 年，DSG 考虑了 238 项新的临床研究， 最终将 86 项（36%）提交给 SRMC，其中 53 项获得批准，29 项在有规定的情况下获得批准，以及 4 人被搁置。没有一个提案被拒绝，这主要是由于 DSG 审查流程的严格性。 2021 年，SRMC 还 完成了 66 项方案修订审查和 131 项继续审查。持续审查的结果是 76 项批准，34 项试用批准，21 项终止。大多数试用期批准与 COVID-19 大流行带来的入学挑战。未来的方向包括缩短时间表 用于 SRMC 批准、无纸化文档以及优化集水区影响。