Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10627036
• 负责人: Kathleen N. Moore
• 金额: $ 20.68万
• 依托单位: UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-01 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10627036
• 关键词: Bioinformatics; Biological Markers; Cancer Center; Cancer Center Support Grant; Catchment Area; Cell Therapy; Child; Clinical; Clinical Cancer Center; Clinical Data; Clinical Investigator; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Communities; Conceptions; Data; Development; Disease; Enrollment; Ensure; Grant; Individual; Inpatients; Institution; Intervention; Intervention Studies; Intervention Trial; Longevity; Minority; Monitor; Patients; Peer Review; Phase; Prevention; Process; Protocols documentation; Publications; Reporting; Research; Research Activity; Research Infrastructure; Research Support; Rural Population; Safety; Science; Serious Adverse Event; Services; Therapeutic Trials; Time; Training; Training and Education; Translational Research; Underserved Population; Woman; Work; Writing; career; clinical research site; data integrity; data management; innovation; investigator-initiated trial; member; outreach; programs; quality assurance; recruit; research study; screening

CLINICAL PROTOCOL AND DATA MANAGEMENT: ABSTRACT The Clinical Protocol and Data Management (CPDM) function provides comprehensive management and support services for clinical research activities at the Stephenson Cancer Center (SCC). CPDM services reside in the SCC’s Clinical Trials Office (CTO), which is comprised of ~200 FTEs and is under the direction of Kathleen Moore, MD (CT), the SCC Associate Director for Clinical Research. The CTO provides centralized and integrated research support services to all SCC members and clinical programs, including comprehensive regulatory support, data management, research coordination embedded in disease-site clinical programs, bioinformatics, quality assurance (auditing and data integrity), finance, and biospecimen acquisition and coordination. For investigator-initiated trials (IITs), a Protocol Support Unit (PSU) provides comprehensive support from protocol conception to activation, registration of new trials, and results reporting with ClinicalTrials.gov. The CTO supports a Data Safety and Monitoring Committee (DSMC) and written DSM Plan (approved by NCI). In addition, it works to ensure accrual to trials by women and children as well as minorities and other individuals in the SCC catchment area historically underrepresented in clinical research. During this grant cycle, several new initiatives were launched to enhance CTO functions, including: 1) implementation of a new CTMS (OnCore) expected to complete in Q3 2022; 2) creation and staffing of a strategic initiative and project management team; 3) creation and staffing of a new Education and Training team and a new Serious Adverse Event (SAE) team; and 4) expansion of the Quality Assurance team and the IIT PSU. In addition, CTO developed a clinical research component for the SCC’s new cellular therapies program inclusive of inpatient research support. Between 2017 and 2021, the CTO oversaw the recruitment, management and reporting of 11,121 individuals into all clinical research studies being conducted within SCC (3,095 interventional treatment, 4,216 interventional non-treatment, 3,810 non-interventional). During this time it facilitated the activation of 524 studies, including 71 institutional and externally peer-reviewed interventional studies. This represents a 100% increase in IITs (interventional) from 2017 to 2021 and a concomitant 40% increase in accruals to interventional IITs between 2017 and 2021. Further, due to intentional outreach to the AI community the percentage of AI enrolled to interventional trials increased from 4.4% to 6.2% across the grant cycle.

临床协议和数据管理：摘要 临床协议和数据管理（CPDM）功能提供了全面的管理和 斯蒂芬森癌症中心（SCC）的临床研究活动的支持服务。 CPDM服务居住 在SCC的临床试验办公室（CTO）中，该办公室已完成约200英尺，在 SCC临床研究副总监凯瑟琳·摩尔（Kathleen Moore），医学博士（CT）。 CTO提供集中 以及为所有SCC成员和临床计划的整合研究支持服务，包括全面 监管支持，数据管理，嵌入在疾病现场临床计划中的研究协调， 生物信息学，质量保证（审计和数据完整性），财务和生物质量获取以及 协调。对于研究人员发动的试验（IIT），协议支持单元（PSU）提供了全面 协议概念到激活的支持，新试验的注册以及结果报告 Clinicaltrials.gov。首席技术官支持数据安全和监测委员会（DSMC）和书面DSM计划 （由NCI批准）。此外，它旨在确保妇女和儿童以及少数民族的审判准确性 以及SCC集水区的其他人历史上没有人为临床研究的代表。在此期间 赠款周期，发起了几项新计划以增强CTO功能，包括：1）实施 新的CTM（ON -CORE）预计将在第三季度2022年完成； 2）创建和人员配备战略倡议和 项目管理团队； 3）创建和人员配备新的教育和培训团队以及一个新的认真 不良事件（SAE）团队； 4）扩大质量保证团队和IIT PSU。另外，CTO 开发了SCC新的蜂窝疗法计划的临床研究组件，包括住院 研究支持。 在2017年至2021年之间，首席技术官监督了11,121个人的招聘，管理和报告 在SCC中进行的所有临床研究中（3,095次介入治疗，4,216 介入的非治疗，3,810非介入）。在此期间，它促进了524的激活 研究，包括71项机构和外部同行评审的介入研究。这代表100％ 从2017年到2021年，IIT（介入）的增加（介入）增加了40％的准确性 2017年至2021年之间的介入IIT。此外，由于有意向AI社区进行宣传 在拨款周期中，参加介入试验的AI百分比从4.4％增加到6.2％。