Protocol Review and Monitoring System

项目摘要--议定书审查和监测系统(PRMS) 在南加州大学诺里斯综合癌症中心(NCCC)，PRMS职能由临床 调查委员会(CIC)，作为中心的科学审查委员会。中投公司为联席主席 作者：Syma Iqbal(Tacs)和Ann Mohrbacher(Tacs)。所有癌症方案都要经过两步审查 提交给IRB。第一步是标准化疾病小组(DT)审查，由临床 调查支助办公室(CISO)DT经理。在目前的资助期内，我们修改了第一阶段 标准化审查并加强DTD和NCCC研究计划之间的互动的过程， 特别是翻译和临床科学(TACS)计划。如果该议定书得到DT的批准，它将 进入第二步，即中投公司的科学审查。只有获得CIC批准的协议才能 由IRB提交和审查。女性、少数族裔和患者在整个生命周期中的收益被考虑在内 在这一进程的每一步，作为评价标准，集水区的相关性也是如此。2019年，中投公司回顾了 117项临床试验，其中25项是机构或外部同行审查的。PRMS的重要新进展 本周期的内容包括：为调查员举行新的强制性“设计和可行性咨询会议”-- 启动试验(IITs)，确保生物统计学家和CISO领导层的早期投入；使用新的 更新的标准化协议模板；以及更严格的DT监督。此外，一个快速激活试点 2018-2019年启动了选择高优先级早期试验的计划，启动时间为8-10年 几周。一旦方案被激活，它们就会由科学委员会监测其应计和科学进展 基于已建立的NCCC应计项目监测的CIC进度和应计项目监测小组委员会 政策。这些流程改进的主要成果包括：1)激活时间表 从2015年的42周减少到2019年的18周，减少了57%；2)新方案CIC审查的平均时间 从会议到完成CIC审查减少了80%(从2015年的5周减少到2019年的1周)；以及3)a) 因应计利润不高而结束的干预试验数量大幅增加(从2015年的11次增加到2019年的20次 2020年为40人)。允许继续开放的低应计利润研究符合特定标准，例如 充分的补救计划，可提高后续监测的应计利润或之前的强劲整体 由于队列关闭而放缓的应计项目。今后的计划包括：a)进一步努力将时间减少到 启动；b)扩大对机构间通信技术的支持，包括对协议编写的支持(2020年启动)，以加强 试验开发的质量和速度；以及c)新的CIC导师计划，以培训初级教师成为 CIC成员和评审员。

PROJECT SUMMARY - Protocol Review and Monitoring System (PRMS) At the USC Norris Comprehensive Cancer Center (NCCC), PRMS functions are performed by the Clinical Investigations Committee (CIC) which serves as the Center's scientific review committee. The CIC is co-chaired by Drs. Syma Iqbal (TACS) and Ann Mohrbacher (TACS). All cancer protocols undergo a two-step review prior to submission to IRB. Step 1 is a standardized Disease Team (DT) review coordinated by the Clinical Investigations Support Office (CISO) DT managers. In the current grant period, we revamped the Stage 1 process to standardize the reviews and enhance interactions between DTs and NCCC Research Programs, particularly the Translational and Clinical Sciences (TACS) Program. If the protocol is approved by the DT, it proceeds to Step 2, the scientific review by the CIC. Only protocols that receive approval by the CIC can be submitted and reviewed by IRB. The accrual of women, minorities, and patients across the lifespan is considered at each step of the process as an evaluation criterion, as is catchment area relevance. In 2019, CIC reviewed 117 clinical trials, 25 of which were institutional or externally peer-reviewed. Important new PRMS developments in the current cycle include: a new mandatory “design and feasibility consultation meeting” for investigator- initiated trials (IITs) which ensures early input from biostatisticians and CISO leadership; usage of a newly updated standardized protocol template; and more rigorous DT oversight. In addition, a rapid activation pilot program for select high priority early phase trials was instituted in 2018-2019 with time to activation of 8-10 weeks. Once protocols are activated, they are monitored for accrual and scientific progress by the Scientific Progress and Accrual Monitoring Subcommittee of the CIC based on an established NCCC accrual monitoring policy. Key accomplishments resulting from these process improvements include: 1) activation timelines have decreased by 57% from 42 weeks in 2015 to 18 weeks in 2019; 2) average time from new protocol CIC review meeting to completion of CIC review decreased by 80% (from 5 weeks in 2015 to 1 week in 2019); and 3) a dramatic increase in the number of interventional trials closed for poor accrual (from 11 in 2015 to 20 in 2019 and 40 in 2020). Low accruing studies that were permitted to remain open met specific criteria, such as an adequate remedial plan that resulted in improved accrual on subsequent monitoring or prior strong overall accrual that slowed down due to cohort closures. Future plans include: a) further efforts to reduce time to activation; b) expansion of support for IITs including protocol writing support (initiated in 2020) to enhance the quality and speed of trial development; and c) a new CIC mentorship program to train junior faculty to become CIC members and reviewers.