Protocol Review and Monitoring System

项目总结/摘要 根据CCSG指南，马基癌症中心（MCC）已建立适当的 通过方案审查确保对癌症临床试验进行严格科学监督的机制， 监测系统（PRMS）。临床护理和研究团队对方案进行初步科学审查 （CCART），包括评估与患者人群的相关性、在产品组合中的适合性和 investigators. 2019年，MCC正式确定了CCART的第一阶段审查，扩大了结构和功能， 以及加强与议定书审查和监测委员会的沟通。以下 CCART批准，由可行性审查委员会完成运营可行性审查。目标 这些审查的目的是确保只有最高质量的试验提交给PRMC。MCC PRMC是 负责对新方案的科学价值、可行性和优先次序进行独立的同行审查。 启动后，PRMC监测正在进行的科学进展的协议，并有最终的权力， 暂停或关闭不符合MCC科学标准协议。PRMS的具体目标是：1） 优化PRMS结构和流程，以获得足够的专业知识规模和广度， 对所有涉及人类受试者的机构癌症相关研究方案进行严格和公平的科学审查; 2)确保在MCC进行的临床试验支持并实现中心的科学使命， 有关的病人在集水区，包括那些来自服务不足的群体，并加强 3）保障所有癌症的科学完整性、可行性和优先性， MCC的相关介入性临床研究，并采用严格的科学审查标准， 4）监督所有介入性癌症临床试验的进展和表现， 确保其继续具有科学价值，并实现《议定书》和《千年挑战委员会》的科学目标。 资助期间的重点包括将第一阶段审查纳入PRMS框架， 加强成员教育，扩大在关键科学领域的代表性，提高法定人数 预期从2019年到2021年，CCART审查了409项临床试验，批准了294项 (72 115人（28%）拒绝;可行性审查委员会因缺乏可行性而拒绝了20人（4%）。 从2019年到2021年，PRMC审查和/或优先考虑了239项新协议，其中230项获得批准， 9人不同意。在过去的三年里，PRMC审查了552项积极的科学进步协议， 由于低累积或科学价值的变化，关闭了29个方案。PRMC不断评估其 自己的业绩。2021年，从PRMC提交到批准的中位时间总体为8天（7个国家，8个国家）， 工业，24个机构）。随着MCC的成熟，PRMS继续优化第一个和第二个 阶段审查，并提高科学的严谨性，客观性和审查每个审判的相关性，我们的多样化 为了确保MCC为阿塞拜疆人带来最高质量的临床研究，

PROJECT SUMMARY/ABSTRACT In accordance with CCSG guidelines, the Markey Cancer Center (MCC) has established appropriate mechanisms for ensuring rigorous scientific oversight of cancer clinical trials through the Protocol Review and Monitoring System (PRMS). Protocols undergo initial scientific review by Clinical Care and Research Teams (CCARTs), including assessment of relevance to the patient population, fit within the portfolio and interest of investigators. In 2019, the MCC formalized first-stage review by CCARTs, expanding structure and function, and enhancing communication with the Protocol Review and Monitoring Committee (PRMC). Following CCART approval, review for operational feasibility is completed by the Feasibility Review Committee. The goal of these reviews is to ensure that only the highest quality trials are submitted to the PRMC. The MCC PRMC is responsible for independent peer-review of scientific merit, feasibility and prioritization of new protocols. Following activation, PRMC monitors protocols for ongoing scientific progress and has ultimate authority to suspend or close protocols that do not meet MCC scientific standards. The Specific Aims of the PRMS are: 1) Optimize the PRMS structure and process for sufficient size and breadth of expertise to conduct a critical, rigorous and fair scientific review of all institutional cancer-related research protocols involving human subjects; 2) Ensure that clinical trials conducted at MCC support and enable the scientific mission of the center, are relevant to patients in the catchment area, including those from underserved groups, and enhance the inclusion of diverse populations; 3) Safeguard the scientific integrity, feasibility and prioritization of all cancer- related interventional clinical research of the MCC and apply rigorous scientific review criteria in a consistent and objective manner; 4) Oversee the progress and performance of all interventional cancer clinical trials to ensure their continued scientific merit and accomplishment of the scientific goals of the protocol and the MCC. Highlights during the funding period include incorporation of first-stage reviews into PRMS framework, enhanced member education, expanded representation in key scientific areas and strengthened quorum expectations. From 2019 to 2021, the CCARTs reviewed 409 clinical trials for potential opening, approved 294 (72%) and declined 115 (28%); the Feasibility Review Committee declined 20 (4%) due to lack of feasibility. From 2019 to 2021, the PRMC reviewed and/or prioritized 239 new protocols, of which 230 were approved and 9 were disapproved. In the past three years, the PRMC reviewed 552 active protocols for scientific progress, closing 29 protocols due to low accrual or a change in scientific merit. The PRMC continuously assesses its own performance. In 2021, median time from PRMC submission to approval was 8 days overall (7 national, 8 industry, 24 institutional). As the MCC has matured, the PRMS has continued to optimize the first- and second- stage review and to increase scientific rigor, objectivity and scrutiny of each trial’s relevance to our diverse population in order to ensure MCC brings the highest quality clinical research to Kentuckians.