Clinical Protocol & Data Management (CPDM)

项目摘要--集中式协议和数据管理 集中式协议和数据管理单元(CPDMU)提供集中式基础设施， 协调和支持阿尔伯特·爱因斯坦癌症中心(AECC)的癌症临床试验 蒙蒂菲奥里卫生系统(MHS)。CPDMU支持议定书审查和监测系统 (PRMS)和数据安全监测委员会(DSMC)，以及AECC实验中心的科学活动 治疗(ET)计划。CPDMU的年度业务预算为450万美元，包括35个FTE 他们支持80名教职员工个人投资。卫生部大幅增加了3名运营经理，专注于 对CPDMU的行政和数据投资(从2017年的266 220美元增加到2018年的570 913美元)。这个 基于VELOS的临床试验/研究管理系统(CTRMS)于2015年推出。CPDMU已经 与教职员工管理层进行了重组-J.Sparano，MD主任，S.Goel，MD( 协议开发)、T.Ow，MD(协议支持联席主任)和B.Halmos，MD(联席主任 精准医学和免疫疗法)。在上一次筹资期间(7/1/13-6/30/18)，全面干预 应计费用增加了22%，干预国家试验的应计费用增加了2.1倍。基于2017年，在肿瘤中 数据表3中反映的登记数据，10.8%的患者登记参加了干预试验，超过 80%的试验参与者是西班牙裔或非裔美国人。在过去3年(7/1/15-6/30/18)， 启动了442项新方案，包括306项干预(15%的机构)和136项不干预(85%) 机构)。CPDMU还支持作为服务不足的少数群体参与NCORP，反映了一个重大的 对NCTN的承诺(去年23%的新治疗试验和32%的治疗收益)。主修 新的倡议包括NCI资助的乳腺癌筛查试验(EA1151-TMIST)、肛门癌 筛查/治疗(锚定)，以及少数民族癌症患者的组织收集(DCP-002，P9846)。

PROJECT SUMMARY - CENTRALIZED PROTOCOL AND DATA MANAGEMENT The Centralized Protocol and Data Management Unit (CPDMU) provides centralized infrastructure, coordination, and support for cancer clinical trials at the Albert Einstein Cancer Center (AECC), a component of the Montefiore Health System (MHS). CPDMU supports the Protocol Review and Monitoring System (PRMS) and Data Safety Monitoring Committee (DSMC), and the scientific activities of the AECC Experimental Therapeutics (ET) Program. The CPDMU, with an annual operating budget of $4.5 million, includes 35 FTEs who support 80 faculty PIs. MHS has substantially increased 3 operational managers focused on administration and data investment in CPDMU (from $266,220 in 2017 to $570,913 projected for 2018). The Velos-based Clinical Trials/Research Management System (CTRMS) was launched in 2015. The CPDMU has been restructured with faculty member management - J. Sparano, MD director, S. Goel, MD (co-director for protocol development), T. Ow, MD (co-director for protocol support), and B. Halmos, MD (Co-director for precision medicine and immunotherapy). During the last funding period (7/1/13-6/30/18), overall intervention accruals increased by 22% and intervention national trial accrual increased 2.1-fold. Based on 2017, in tumor registry data reflected in Data Table 3, 10.8% of patients were enrolled on intervention trials, and more than 80% of trial participants were Hispanic or African-American. During the last 3-years (7/1/15-6/30/18), there were 442 new protocols activated, including 306 intervention (15% institutional) and 136 non-intervention (85% institutional). The CPDMU also supports participation as a Minority Underserved NCORP, reflecting a major commitment to the NCTN (23% of new therapeutic trials and 32% of therapeutic accruals last year). Major new initiatives include NCI-funded trials in breast cancer screening (EA1151-TMIST), anal cancer screening/treatment (ANCHOR), and tissue collection in minorities with cancer (DCP-002, P9846).