Protocol Review and Monitoring System

项目摘要/摘要 马基癌症中心(MCC)的临床研究使命是进行最高质量的研究 癌症的原因和治疗。根据CCSG为国家癌症研究所制定的指南- 指定的癌症中心，MCC已经建立了适当的机制，以确保严格的科学 通过议定书审查和监测系统对与癌症有关的临床试验进行审查和监督 (PRMS)。MCC协议审查和监测委员会(PRMC)负责独立的Peer 审查新方案的科学价值、可行性和优先顺序，并监测所有科学试验 进展和应计(包括未达到MCC科学目标的研究的终止)。 方案在疾病组审查后提交给PRMC，称为临床护理和 研究团队(CCART)，以符合投资组合和调查人员的认可，并由 可行性审查委员会(FRC)的业务可行性。事先审查的目标和委员会的投入 CCART和FRC将丰富提交给PRMC的议定书的科学性和轻重缓急。这个 PRMC确保所有涉及人类受试者的介入性癌症研究在 MCC的主持：1)服务和支持MCC的使命，包括确定研究试验的优先顺序 与集水区需求相关；2)具有很高的科学价值；3)在统计上是合理和适当的 设计；4)根据现有患者群体和在以下情况下及时完成工作是可行的 目前的试验组合；5)根据MCC标准并根据积极积累的试验确定优先顺序；以及6) 包括服务不足的人群(例如，妇女、少数群体、儿童)。激活后，协议是 由PRMC根据MCC政策监测持续的科学进步和应计费用。PRMC拥有终极 因科学价值的低收益或重大变化而暂停或关闭方案的权力，以及 负责在及时审查试验过程中持续监测其效率和质量。 在这一供资期间，PRMS在程序和政策方面有了重大改进 最新消息。具体而言，PRMS通过增加高级审查员来加强其审查过程的科学严谨性， 标准化审查标准和评分，并采用更严格的应计项目监测做法 有一个新的主席和联合主席，没有与其他临床研究机构的利益冲突，以及 PRMC的成员目前主要由高级教员和更多不同的科学学科组成。从… 2013至2016年，PRMC审查和/或确定了284项新议定书的优先顺序，其中264项(93%)获得批准 20个(7%)不被批准；审查了279个现行的科学进步议定书，关闭了37个议定书 由于低收益或科学价值的变化。随着MCC的发展，PRMS将继续严格的科学 审查方案，确定适当的优先顺序，遵守MCC的使命，并纳入具有 与肯塔基州集水区相关的科学焦点。

PROJECT SUMMARY/ABSTRACT The Markey Cancer Center's (MCC) clinical research mission is to conduct the highest quality research into the causes and treatment of cancer. In accordance with the CCSG guidelines for National Cancer Institute- designated Cancer Centers, MCC has established appropriate mechanisms for assuring rigorous scientific scrutiny and oversight of cancer-relevant clinical trials through the Protocol Review and Monitoring System (PRMS). The MCC Protocol Review and Monitoring Committee (PRMC) is responsible for independent peer review of scientific merit, feasibility, and prioritization of new protocols, and monitoring all trials for scientific progress and accrual (including termination of studies not meeting MCC scientific goals). Protocols are submitted to the PRMC following review by disease groups, called Clinical Care and Research Teams (CCARTs), for fit with the portfolio and endorsement by investigators, and review by the Feasibility Review Committee (FRC) for operational feasibility. The goal of prior review and input by the CCARTs and FRC is to enrich the scientific quality and prioritization of protocols submitted to the PRMC. The PRMC ensures that all interventional cancer research studies involving human subjects conducted under the auspices of the MCC: 1) serve and support the mission of MCC including prioritization of research trials relevant to catchment area needs; 2) have high scientific merit; 3) are statistically sound and appropriately designed; 4) are feasible for timely completion based on the available patient population and in the context of the current trial portfolio; 5) are prioritized, based on MCC criteria and in light of actively accruing trials; and 6) are inclusive of underserved populations (e.g., women, minorities, children). After activation, protocols are monitored by the PRMC for ongoing scientific progress and accrual per MCC policy. The PRMC has ultimate authority to suspend or close protocols for low accrual or significant change in scientific merit, and the responsibility for continuous monitoring of its efficiency and quality in the timely review of trials. During this funding period, the PRMS has undergone significant improvement in procedures and policy updates. Specifically, the PRMS enhanced scientific rigor of its review process by increasing senior reviewers, standardizing review criteria and scoring, and adopting more stringent accrual monitoring practices The PRMS has a new Chair and Co-chair free from conflicts of interest with the other clinical research bodies, and the PRMC members now comprises mainly senior faculty and a greater diversity of scientific disciplines. From 2013 to 2016, the PRMC reviewed and/or prioritized 284 new protocols, of which 264 (93%) were approved and 20 (7%) were disapproved; and reviewed 279 active protocols for scientific progress, closing 37 protocols due to low accrual or a change in scientific merit. As the MCC grows, the PRMS will continue rigorous scientific review of protocols, appropriate prioritization, adherence to MCC's mission, and inclusion of trials with a scientific focus relevant to the catchment area of Kentucky.