Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10177900
• 负责人: ADAM S ASCH
• 金额: $ 6.56万
• 依托单位: UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10177900
• 关键词: Adherence; Budgets; Cancer Center; Cancer Center Support Grant; Clinical; Clinical Research; Clinical Trials; Committee Membership; Conduct Clinical Trials; Cost Allocation; Development; Discipline; Disease; Enrollment; Ensure; Foundations; Goals; Institutional Policy; Institutional Review Boards; Knowledge; Leadership; Malignant Neoplasms; Medical Research; Monitor; Oklahoma; Process; Protocols documentation; Research Personnel; Research Priority; Research Support; Resources; Review Committee; Site; System; Voting; authority; base; cancer research center director; design; experience; investigator-initiated trial; member; multidisciplinary; operation; patient population; programs; research study

PROTOCOL REVIEW AND MONITORING SYSTEM – ABSTRACT The Protocol Review and Monitoring System (PRMS) oversees all cancer-related clinical research at the Stephenson Cancer Center (SCC), including clinical research at the Oklahoma Medical Research Foundation (the SCC's proposed consortium partner), in order to ensure that it is of the highest scientific merit, adheres to the strategic priorities of the SCC, demonstrates ongoing progress and efficiently utilizes SCC resources. The PRMS conducts protocol review in a two-stage process. In stage one, Multidisciplinary Disease-Site Committees (MDCs) initiate and/or review protocols (when disease-based) proposed by member investigators in order to assess scientific merit, availability of relevant patient population, overlap with potentially competing trials and whether protocols align with disease-site program goals. The MDC also assists investigators in the development of investigator-initiated trials (IITs). The SCC's Budget and Operations Committee (BOC), which is comprised of the leadership of the Clinical Trials Office (CTO) and SCC Administrative Core, reviews all new institutional protocols to ensure effective CTO resource utilization, operational feasibility and appropriateness of cost allocation. In stage two, the Protocol Review and Monitoring Committee (PRMC) conducts an independent review of the protocol to assess scientific merit and design feasibility. The SCC Director has delegated to the PRMC the institutional authority to open protocols that meet SCC standards for scientific merit and scientific priorities and to terminate protocols that do not demonstrate scientific progress. PRMC membership includes broad representation from multiple disciplines engaged in cancer clinical research. Its 21 voting members are selected based on their disciplinary-specific knowledge, experience in designing and conducting research studies, and/or specialized clinical expertise. Depending on trial type, the PRMC performs either an expedited Administrative Review or Full Committee Review. If the latter, at least two reviewers from the PRMC voting members are assigned to the protocol. A protocol is approved with a majority vote of a quorum of members. PRMC review occurs prior to submission to the Institutional Review Board (IRB), and per institutional policy the latter will not review cancer-related protocols until approved by the PRMC. In 2016, the PRMC reviewed 114 new protocols. The PRMC also monitors active protocols annually for ongoing accrual and has the authority to close protocols that do not demonstrate adequate scientific progress. A focused process designed to enhance accrual to low enrolling trials is also part of the PRMC. In 2016, the PRMC reviewed 73 active protocols for accrual progress. Of these, 41 were approved to continue, 27 were required to submit Accrual Enhancement Plans, and five were closed due to low accrual.

方案审查和监测系统-摘要 方案审查和监测系统（PRMS）监督所有癌症相关的临床研究， 斯蒂芬森癌症中心（SCC），包括俄克拉荷马州医学研究基金会的临床研究 (the SCC的拟议财团合作伙伴），以确保其具有最高的科学价值，坚持 SCC的战略优先事项，展示持续的进展并有效地利用SCC资源。的 PRMS分两个阶段进行方案审查。在第一阶段，多学科疾病-网站 委员会（MDC）启动和/或审查成员研究者提出的方案（当基于疾病时） 为了评估科学价值、相关患者人群的可用性、与潜在竞争药物的重叠 试验以及方案是否与疾病部位计划目标一致。MDC还协助调查人员 开展药物启动试验（IIT）。SCC的预算和运营委员会（BOC）， 由临床试验办公室（CTO）和SCC行政核心的领导层组成， 确保CTO资源有效利用、业务可行性和适当性的机构协议 成本分配。在第二阶段，方案审查和监测委员会（PRMC）进行了一项 独立审查方案，以评估科学价值和设计可行性。SCC主任已 授予PRMC公开符合SCC科学价值标准的方案的机构权力 和科学优先事项，并终止不能证明科学进步的议定书。 PRMC成员包括从事癌症临床研究的多个学科的广泛代表性 research.其21名有投票权的成员是根据他们的学科知识， 设计和进行研究，和/或专门的临床专业知识。根据试验类型， PRMC执行快速行政审查或全面委员会审查。如果是后者，至少有两个 来自PRMC投票成员的审查员被分配到方案。一项协议以多数票通过 法定人数的成员投票。在提交给机构审查委员会之前进行PRMC审查 (IRB)，根据机构政策，后者在获得 PRMC。2016年，PRMC审查了114项新协议。PRMC还每年监测活动协议， 该委员会还有权关闭未显示出充分科学进展的方案。 PRMC还包括一个重点流程，旨在提高低入组试验的应计率。2016年 PRMC审查了73项活动方案的应计进度。其中，41个被批准继续，27个被 有5个项目因应计额低而关闭。