Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10332413
• 负责人: SYMA IQBAL
• 金额: $ 16.09万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-12-01 至 2026-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10332413
• 关键词: California; Cancer Center Support Grant; Catchment Area; Clinical Protocols; Clinical Sciences; Clinical Trials; Committee Members; Comprehensive Cancer Center; Consultations; Development; Disease; Documentation; Ensure; Evaluation; Faculty; Future; Grant; Institutes; Institutional Review Boards; Intervention Studies; Intervention Trial; Last Name; Leadership; Longevity; Malignant Neoplasms; Mentorship; Minority; Minority Recruitment; Minority Women; Monitor; NCI Center for Cancer Research; Names; Patients; Peer Review; Policies; Process; Protocols documentation; Research Design; Review Committee; Speed; Standardization; System; Systems Development; Time; TimeLine; Training; Translational Research; Universities; University of Southern California Norris Cancer Center; Update; Woman; Writing; base; clinical investigation; cohort; design; early phase trial; flexibility; improved; investigator-initiated trial; meetings; member; molecular subtypes; multidisciplinary; phase 1 study; programs; rare cancer

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.

项目总结-方案审查和监测系统（PRMS） 在南加州大学诺里斯综合癌症中心（NCCC），PRMS功能由临床 调查委员会（CIC）是该中心的科学审查委员会。CIC是联合主席 作者：Syma Iqbal（TACS）和Ann Mohrbacher（TACS）。所有的癌症治疗方案都要经过两步审查， 提交给IRB。第1步是由临床协调的标准化疾病小组（DT）审查 调查支助办公室（CISO）DT管理人员。在本资助期内，我们重整了 标准化评审程序，并加强DTs和NCCC研究计划之间的互动， 特别是转化和临床科学（TACS）计划。如果方案得到DT批准， 进入步骤2，由CIC进行科学审查。只有获得CIC批准的协议才能 由IRB提交和审查。考虑了妇女、少数民族和患者在整个生命周期中的累积 在这一过程的每一步，作为一个评价标准，因为是集水区的相关性。2019年，中投公司审核了 117项临床试验，其中25项是机构或外部同行评审。PRMS的重要新发展 包括：新的强制性“设计和可行性咨询会议”，供研究人员- 启动试验（IIT），确保生物统计学家和CISO领导层的早期投入;使用新的 更新标准化方案模板;更严格的DT监督。此外，快速激活试点 2018-2019年制定了选择高优先级早期试验的计划，激活时间为8-10 周一旦协议被激活，科学委员会将监测它们的累积和科学进展。 根据已建立的NCCC应计监测，CIC的进度和应计监测小组委员会 政策这些流程改进带来的主要成就包括：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 会议至完成CIC审查的时间减少80%（由2015年的5周减少至2019年的1周）;及3）a 因不良累积而关闭的干预性试验数量急剧增加（从2015年的11项增加到2019年的20项 2020年40人）。允许保持开放的低累积研究符合特定标准，例如 充分的补救计划，导致后续监控或之前强劲的整体收益得到改善 由于队列关闭，增长放缓。今后的计划包括：（a）进一步努力减少 激活; B）扩大对IIT的支持，包括方案编写支持（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， CIC成员和评审员。