Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10627037
• 负责人: ADAM S ASCH
• 金额: $ 7.98万
• 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 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10627037
• 关键词: Authorization documentation; Cancer Center; Cancer Center Support Grant; Clinical; Clinical Cancer Center; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Committee Members; Committee Membership; Conduct Clinical Trials; Data; Discipline; Disease; Doctor of Philosophy; Elements; Ensure; Evaluation; Goals; Guidelines; Health Sciences; Institution; Institutional Policy; Institutional Review Boards; Knowledge; Letters; Life Cycle Stages; Malignant Neoplasms; Monitor; Oklahoma; Patients; Process; Protocols documentation; Research; Research Personnel; Research Priority; Research Support; Resources; Review Committee; Safety; System; Universities; Voting; Writing; advanced disease; anticancer research; authority; data management; design; experience; human subject; member; patient population; research study; tool; tumor progression

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) 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, with Stage One involving Disease Groups (DGs) and a Feasibility Review Committee (FRC) and Stage Two involving the Protocol Review and Monitoring Committee (PRMC) for a separate, independent review. PRMS coordinators support investigators and committee members in navigating the two required stages of review for all applicable studies. Studies approved by the PRMC are monitored throughout the lifecycle of the study. Independent Disease Groups (DGs) review new concepts and protocols to assess scientific merit, availability of the relevant patient population, overlap with potentially competing trials, and whether protocols align with and advance DG- and SCC-based goals. DGs assign a priority score to each study utilizing a Prioritization Schema that reflects the overall research priorities of the SCC. This discussion tool guides the evaluation of new protocols to assess the availability of patients and estimate the number of local patients anticipated based on SCC’s patient population. In 2021, DGs reviewed 286 new protocols; 126 (44%) were not approved to continue to the PRMC. The SCC’s PRMC is chaired by Adam Asch, MD (CT) and co-chaired by Melissa Craft, BSN, MS CNS, PhD (CPC affiliate). PRMC membership includes broad representation from multiple disciplines engaged in cancer clinical research. Its 18 voting members are selected based on their disciplinary-specific knowledge, experience in design and conduct of 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 2021, the PRMC reviewed 145 new protocols (128 approved, 9 approved with revision, 4 tabled and 4 disapproved). The PRMC also monitors active protocols annually for ongoing accrual and has the authority to close protocols that do not demonstrate adequate scientific progress. In 2021, the PRMC reviewed 514 active protocols for accrual progress. Of these, 335 were approved to continue, 168 were required to submit Accrual Enhancement Plans, and 11 were closed.

方案审查和监测系统：摘要 方案审查和监测系统 (PRMS) 负责监督所有与癌症相关的临床研究 史蒂芬森癌症中心 (SCC) 为确保其具有最高的科学价值，坚持战略 SCC 的优先事项、展示持续进展并有效利用 SCC 资源。计划风险管理系统 分两个阶段进行方案审查，第一阶段涉及疾病组 (DG) 和 可行性审查委员会 (FRC) 和涉及方案审查和监测委员会的第二阶段 (PRMC) 进行单独、独立的审查。 PRMS 协调员为调查人员和委员会提供支持 成员完成所有适用研究所需的两个审查阶段。研究获批准 PRMC 在研究的整个生命周期中受到监控。 独立疾病组 (DG) 审查新概念和方案以评估科学价值和可用性 相关患者群体的情况、与潜在竞争试验的重叠以及方案是否与 并推进基于 DG 和 SCC 的目标。总干事利用优先级为每项研究分配优先级分数 反映 SCC 整体研究重点的架构。该讨论工具指导评估 新方案评估患者的可用性并根据预期估计当地患者的数量 关于 SCC 的患者群体。 2021 年，总干事审查了 286 项新协议； 126 (44%) 未获批准 继续前往 PRMC。 SCC 的 PRMC 由 Adam Asch（医学博士（CT））担任主席，联合主席由 Melissa Craft（BSN、MS CNS、PhD） （中国共产党附属机构）。 PRMC 成员包括来自癌症研究多个学科的广泛代表 临床研究。其 18 名投票成员是根据其特定学科知识选出的， 设计和进行研究的经验，和/或专业的临床专业知识。取决于试用 类型，PRMC 执行快速行政审查或全面委员会审查。如果是后者，则在 至少有两名来自 PRMC 投票成员的审稿人被分配给该方案。协议经批准 法定人数的多数票。 PRMC 审查在提交机构审查之前进行 委员会 (IRB)，并且根据机构政策，在获得委员会批准之前，后者不会审查与癌症相关的方案 PRMC。 2021 年，PRMC 审查了 145 项新方案（其中 128 项获得批准，9 项经修订批准，4 项已提交并批准） 4 不同意）。 PRMC 还每年监控有效协议的持续累积情况，并有权 关闭未证明足够科学进展的协议。 2021 年，PRMC 审查了 514 个活跃项目 应计进度协议。其中，335 家获准继续，168 家需要提交应计费用 增强计划，11 个已关闭。