Clinical Protocol and Data Management

项目摘要-临床方案和数据管理(CPDM) 在南加州大学诺里斯综合癌症中心(NCCC)，临床研究支持办公室(CISO) 作为所有癌症试验的中央临床试验办公室，独立于发端部门或疾病 一队。CISO的高级领导包括担任医务主任的Anthony El-Khoueary MD， 凯文·凯利医学博士担任助理医务主任，Zeno Ashai MBBS公共卫生硕士被任命 2019年担任副主任。CISO有三个单位：质量保证和合规股、监管部门 该股和研究业务股。CISO还支持四个临床研究监督委员会 (临床调查委员会、数据安全及监察委员会、品质保证委员会及 第一阶段委员会)。在当前时期，CISO为疾病团队经理创建了一个角色，负责监督 在疾病小组方案审查的第一步中，研究工作人员并支持十个疾病小组。值得注意的是，CISO 还扩大和加强了服务，以支持这一批款期内的调查员发起试验(IITs)， 包括：新议定书制定支助(设计和可行性协商会议)、增加议定书 作者，Medidata Rave数据库开发，用于介入方案和多站点协调服务 (使NCCC能够在适当时作为多地点研究所的协调地点；协调了14项此类试验 2019年)。赠款期间的其他成就包括：1)广泛的CISO重组，包括 增加20名全职员工(FTE)，使上述服务得以扩展；2)全面实施 OnCore临床试验管理系统；3)介入试验从816项增加43.5% 从2015年的患者减少到2019年的1171人(其中223人(29%)是IIT)；4)激活时间从 从2015年的42周减少到2019年的18周；5)提高了机构间投资信托基金的质量，将反对率降至 初步PRMS审查从2015年的35%提高到2019年的17%；以及6)少数族裔在干预中的可观收益 试验(2019年应计利润的61.6%来自临床试验中代表性不足的少数群体)。尽管有COVID- 19大流行，从2020年1月1日至2020年11月30日，共有659名患者参加了干预试验。

PROJECT SUMMARY - Clinical Protocol and Data Management (CPDM) At the USC Norris Comprehensive Cancer Center (NCCC), the Clinical Investigations Support Office (CISO) serves as the centralized clinical trials office for all cancer trials, independent of originating department or disease team. The senior CISO leadership includes Anthony El-Khoueiry MD who serves as the Medical Director, Kevin Kelly MD who serves as the Assistant Medical Director, and Zeno Ashai MBBS MPH who was appointed as Associate Director in 2019. CISO has three units: the Quality Assurance and Compliance Unit, the Regulatory Unit and the Research Operations Unit. CISO also supports the four clinical research oversight committees (Clinical Investigations Committee, Data Safety and Monitoring Committee, Quality Assurance Committee, and Phase I Committee). In the current period, CISO created a role for Disease Team Managers who supervise research staff and support the ten Disease Teams in Step 1 of Disease Team protocol reviews. Notably, CISO also expanded and enhanced services to support investigator initiated trials (IITs) over this grant period, including: new protocol development support (design and feasibility consultation meetings), addition of a protocol writer, Medidata Rave database development for interventional protocols, and multisite coordination services (enabling NCCC to serve as a coordinating site for multi-site IITs when appropriate; 14 such trials coordinated in 2019). Additional accomplishments over the grant period include: 1) an extensive CISO reorganization with addition of 20 full time employees (FTEs), enabling expansion of services cited above; 2) full implementation of the OnCore clinical trials management system; 3) a 43.5% increase in interventional trial accruals from 816 patients in 2015 to 1171 in 2019 (of which 223 (29%) were IITs); 4) a 57% decrease in time to activation from 42 weeks in 2015 to 18 weeks in 2019; 5) improvement in the quality of IITs that reduced the disapproval rate at the initial PRMS review from 35% in 2015 to 17% in 2019; and 6) substantial accrual of minorities in interventional trials (61.6% of 2019 accruals are from minority groups underrepresented in clinical trials). Despite the COVID- 19 pandemic, 659 patients were accrued to interventional trials from 1/1/2020 to 11/30/2020.