Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10627514
• 负责人: R. Donald Harvey
• 金额: $ 30.16万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-07 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10627514
• 关键词: Adult; Adverse event; Authorization documentation; Awareness; Black race; Cancer Center Support Grant; Cancer Patient; Cancer Therapy Evaluation Program; Catchment Area; Childhood; Clinical Data; Clinical Management; Clinical Nursing Research; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Network; Competence; Conduct Clinical Trials; Continuing Education; Data; Data Analyses; Data Collection; Development; Doctor of Pharmacy; Doctor of Philosophy; Documentation; Education; Electronics; Enrollment; Ensure; Ethics; Faculty; Funding; Generations; Goals; Guidelines; Industry; Infrastructure; Institution; Intervention; Investigational Therapies; Laboratory Research; Leadership; Malignant Neoplasms; Measures; Modality; Monitor; National Clinical Trials Network; Patients; Peer Review; Performance; Persons; Physician Executives; Physicians; Protocol Compliance; Protocols documentation; Reporting; Research; Research Activity; Research Infrastructure; Research Personnel; Safety; Site; Specialist; Structure; System; Therapeutic Clinical Trial; Therapeutic Trials; Time; Training; Training and Education; Translations; Underrepresented Populations; Universities; authority; black patient; cancer site; cancer therapy; clinical infrastructure; clinical translation; data management; experience; falls; improved; innovation; member; novel; operation; outreach; pandemic disease; phase I trial; programs; recruit; treatment trial; working group

PROJECT SUMMARY/ABSTRACT CLINICAL PROTOCOL AND DATA MANAGEMENT The Clinical Protocol and Data Management (CPDM) oversees all cancer clinical research at Winship Cancer Institute of Emory University (Winship). CPDM has three objectives: (1) supporting safe and ethical conduct of innovative and transformative clinical research; (2) promoting high-quality data generation; and (3) increasing trial access for patients in the catchment area, emphasizing underrepresented populations. CPDM includes the Winship Clinical Trials Office (CTO), clinical data management team, regulatory specialists, quality management (QM), training/education, and the Data Safety and Monitoring Committee (DSMC). This research infrastructure is led by interim Associate Director for Clinical Research Edmund Waller, MD, PhD (CI), and CTO Medical Director R. Donald Harvey, PharmD (DDT), under the direct leadership of Winship Executive Director Suresh Ramalingam, MD (DDT). CTO operational leadership is provided by CTO Director Amy Overby, who oversees all clinical research staff and a group of experienced managers across each CTO function. The CTO provides infrastructure including trial development, activation, conduct, data collection and analysis, and QM monitoring (including in-person/remote site) and audits with a specialized team focused on multi-institutional trials. In addition, the CTO provides orientation and ongoing training for Winship members, faculty, and staff across all aspects of clinical research. The clinical data management team and regulatory specialists are organized by cancer site and treatment modality working groups. The Winship trials portfolio is balanced between institutional, industry-sponsored, externally peer-reviewed, and NCI-supported National Clinical Trials Network (NCTN) and Experimental Therapeutics Clinical Trials Network (ETCTN) trials. The DSMC oversees implementation of the Winship Data Safety and Monitoring Plan (DSMP) to ensure a high level of compliance. During the 2017-2021 funding period, 936 interventional and non-interventional protocols were activated at Winship. CPDM also supported the recruitment of 3,940 accruals to interventional treatment trials (representing a 23% increase compared to prior reporting period) across 732 protocols; approximately 41% of enrollments were on institutional or externally peer-reviewed trials. Of these, Black patients comprise 25% of the interventional treatment accruals at Winship, which is comparable to the proportion of Black cancer patients in Georgia. The DSMC monitored 358 protocols, resulting in 549 reviews of IITs and national group trials. Analyses of performance metrics for trial conduct demonstrate steady improvements in key measures including accrual, activation times, and protocol compliance. Currently 333 adult therapeutic clinical trials, and 97 pediatric therapeutic trials are open to enrollment at Winship. During the next funding period, Winship will continue to increase patient accrual with an emphasis on the affiliate sites and continued focus on historically underrepresented groups.

项目摘要/摘要 临床协议和数据管理 临床方案和数据管理（CPDM）监督Winship Cancer的所有癌症临床研究 埃默里大学研究所（Winship）。 CPDM有三个目标：（1）支持安全和道德的行为 创新和变革性的临床研究； （2）促进高质量的数据生成； （3）增加 集水区患者的试用访问，强调代表性不足的人群。 CPDM包括 Winship临床试验办公室（CTO），临床数据管理团队，监管专家，质量管理 （QM），培训/教育以及数据安全与监测委员会（DSMC）。这项研究基础设施 由临床研究副总监Edmund Waller，医学博士，博士（CI）和CTO Medical领导 在Winship执行董事Suresh的直接领导下，PharmD（DDT）的R. Donald Harvey主任R. Donald Harvey（DDT） 马里兰州拉马灵姆（DDT）。首席技术官运营领导由CTO主管Amy Overby提供，他负责 每个CTO功能中的所有临床研究人员和一群经验丰富的经理。 CTO提供 基础架构，包括试验开发，激活，行为，数据收集和分析以及QM监视 （包括面对面/远程网站）和由专门研究多机构试验的专业团队进行审核。在 此外，首席技术官为胜利船员，教职员工提供了定向和持续的培训 临床研究的各个方面。临床数据管理团队和监管专家由 癌症部位和治疗方式工作组。 Winship Trials投资组合在机构之间保持平衡 由行业赞助的，外部同行评审和NCI支持的国家临床试验网络（NCTN）和 实验治疗临床试验网络（ETCTN）试验。 DSMC监督实施 Winship数据安全和监测计划（DSMP），以确保高水平的合规性。在2017 - 2021年期间 筹资期在Winship中激活了936个介入和非介入方案。 CPDM也是如此 支持招募3,940名应计介入治疗试验（占23％ 与以前的报告期相比）跨732个协议；大约41％的入学人数是机构 或外部同行评审试验。其中，黑人患者占介入治疗应计的25％ 在Winship上，这与佐治亚州黑人癌患者的比例相当。 DSMC监视 358个协议，对IIT和国家小组试验进行了549项审查。绩效指标的分析 行为表明关键措施的稳定改善，包括应计激活时间和协议 遵守。目前，有333次成人治疗临床试验和97个儿科治疗试验开放 Winship的入学人数。在下一个资金期间，Winship将继续增加患者的应计。 强调会员站点，并继续专注于历史上代表性不足的群体。