Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10620212
• 负责人: Anthony Boutros El-Khoueiry
• 金额: $ 72.92万
• 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/10620212
• 关键词: Administrator; Asian; Black race; COVID-19 pandemic; California; Cancer Center Support Grant; Case Report Form; Catchment Area; Clinical; Clinical Cancer Center; Clinical Data; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Communities; Community Outreach; Comprehensive Cancer Center; Consultations; Data; Data Science; Databases; Development; Disease; Education and Outreach; Eligibility Determination; Employee; Ensure; Environment; Evaluation; Faculty; Generations; Grant; Institution; Intervention Trial; Last Name; Leadership; Longevity; Malignant Neoplasms; Medidata; Minority; Minority Groups; Mission; Monitor; Names; Operations Research; Participant; Patients; Phase; Physician Executives; Procedures; Process; Protocols documentation; Regulation; Reporting; Research; Research Personnel; Resource Sharing; Role; Safety; Services; Site; Standardization; Supervision; System; Time; Training; Underrepresented Populations; Universities; University of Southern California Norris Cancer Center; Update; Woman; Work; cancer clinical trial; clinical investigation; community engagement; data management; design; education planning; financial toxicity; improved; investigator-initiated trial; meetings; member; minority patient; multidisciplinary; programs; protocol development; quality assurance; service coordination; skills; therapy development; tool

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.

项目总结-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集中临床试验办公室，独立于原始部门或疾病 团队高级CISO领导层包括Anthony El-Khoueiry医学博士，他担任医学总监， Kevin Kelly医学博士担任助理医学总监，Zeno Ashai MBBS MPH被任命为 2019年担任副主任。首席信息安全干事有三个单位：质量保证和合规股、 股和研究业务股。CISO还支持四个临床研究监督委员会 （临床研究委员会、数据安全和监测委员会、质量保证委员会和 第一阶段委员会）。在当前阶段，CISO为疾病团队经理创造了一个角色， 研究人员，并支持疾病小组方案审查第1步中的10个疾病小组。特别是，CISO 还扩大和加强了服务，以支持研究者发起的试验（IIT）在这一赠款期间， 包括：新方案开发支持（设计和可行性协商会议），增加一项方案 作者，Medidata Rave介入协议数据库开发和多中心协调服务 （使NCCC能够在适当时作为多中心IIT的协调中心;协调了14项此类试验 2019年）。在赠款期间取得的其他成就包括：1）广泛的首席信息安全官重组， 增加20名全职员工，扩大上述服务; 2）全面实施 OnCore临床试验管理系统; 3）干预性试验应计费用从816 患者从2015年的1171例减少到2019年的1171例（其中223例（29%）为IIT）; 4）激活时间从2015年的1171例减少到2019年的1171例（其中223例（29%）为IIT）; 从2015年的42周减少到2019年的18周; 5）IIT质量的提高，降低了 初步PRMS审查从2015年的35%增加到2019年的17%;以及6）少数民族在干预性研究中的大量增加 临床试验（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- 2020年1月1日至2020年11月30日，659名患者参与了干预性试验。