Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10620219
• 负责人: SYMA IQBAL
• 金额: $ 15.96万
• 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/10620219
• 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; Female; Future; Grant; Institution; Institutional Review Boards; Intervention Studies; Intervention Trial; Last Name; Leadership; Longevity; Malignant Neoplasms; Medial; Mentorship; Minority; Minority Recruitment; Monitor; NCI Center for Cancer Research; Names; Patients; Peer Review; Policies; Process; Protocols documentation; Research Design; Review Committee; Speed; Standardization; System; Systems Development; Time; Training; Translational Research; Universities; University of Southern California Norris Cancer Center; Update; Woman; Writing; clinical investigation; cohort; design; early phase trial; flexibility; improved; investigator-initiated trial; meetings; member; molecular subtypes; multidisciplinary; phase 1 study; process improvement; programs; rare cancer; timeline

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.

项目摘要 - 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 职能由临床部门执行 调查委员会（CIC）作为该中心的科学审查委员会。 CIC 担任联合主席 由博士。 Syma Iqbal (TACS) 和 Ann Mohrbacher (TACS)。所有癌症方案均经过两步审查 提交给IRB。第 1 步是由临床部门协调的标准化疾病小组 (DT) 审查 调查支持办公室 (CISO) DT 经理。在当前的资助期内，我们修改了第一阶段 标准化审查并加强 DT 和 NCCC 研究计划之间互动的流程， 特别是转化和临床科学（TACS）计划。如果该协议得到 DT 的批准，则 进入第二步，由 CIC 进行科学审查。只有获得 CIC 批准的协议才可以 由IRB提交并审核。考虑了女性、少数族裔和患者整个生命周期的收益 流程的每一步都作为评价标准，流域相关性也是如此。 2019年，中投公司审核 117 项临床试验，其中 25 项经过机构或外部同行评审。 PRMS 的重要新进展 当前周期包括： 为研究者举行新的强制性“设计和可行性咨询会议” 启动试验 (IIT)，确保生物统计学家和 CISO 领导层尽早提供意见；使用新的 更新了标准化协议模板；以及更严格的数据传输监督。此外，快速启动试点 2018-2019 年启动了选定的高优先级早期试验计划，启动时间为 8-10 几周。一旦协议被激活，科学委员会就会监控其应计和科学进展。 CIC 的进度和应计监测小组委员会基于既定的 NCCC 应计监测 政策。这些流程改进所取得的主要成就包括：1) 激活时间表已缩短 从2015年的42周减少到2019年的18周，减少了57%； 2）新方案CIC审核平均时间 会议到完成CIC审查的时间减少了80%（从2015年的5周减少到2019年的1周）； 3) 一个 因应计效果不佳而结束的干预试验数量急剧增加（从 2015 年的 11 项增加到 2019 年的 20 项） 2020 年将达到 40 个）。允许保持开放的低收益研究符合特定标准，例如 适当的补救计划，导致后续监测或之前的总体总体收益提高 由于队列关闭，应计增长放缓。未来的计划包括： a) 进一步努力减少时间 激活; b) 扩大对个人所得税的支持，包括协议编写支持（2020 年启动），以增强 试验开发的质量和速度； c) 一项新的 CIC 指导计划，旨在培训初级教师成为 CIC 成员和审稿人。