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.

临床方案和数据管理：摘要 临床方案和数据管理（CPDM）功能提供全面的管理， 斯蒂芬森癌症中心（SCC）临床研究活动的支持服务。CPDM服务驻留在 在SCC的临床试验办公室（CTO），由约200名FTE组成，并在以下人员的指导下工作： Kathleen摩尔，医学博士（CT），SCC临床研究副主任。CTO提供集中的 为所有SCC成员和临床项目提供综合研究支持服务， 监管支持，数据管理，嵌入疾病现场临床计划的研究协调， 生物信息学、质量保证（审计和数据完整性）、财务和生物标本采集， 协同对于药物启动试验（IIT），方案支持部门（PSU）提供全面的 支持从方案构思到启动、新试验注册和结果报告， CTO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，它还努力确保妇女和儿童以及少数民族能够参加审判 以及SCC集水区的其他个体在临床研究中的代表性历来不足。在此 在赠款周期内，推出了几项新举措，以加强CTO的职能，包括：1）实施 新的CTMS（OnCore）预计将于2022年第三季度完成; 2）创建战略计划并配备人员， 项目管理团队; 3）创建一个新的教育和培训团队以及一个新的严肃的 不良事件（SAE）团队;以及4）扩大质量保证团队和IIT PSU。此外，CTO 为SCC的新细胞疗法项目开发了临床研究部分，包括住院患者 研究支持。 2017年至2021年间，首席技术官监督了11，121名人员的招聘、管理和报告 在SCC中进行的所有临床研究中（3，095例介入治疗，4，216例 干预性非治疗，3 810例非干预性）。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干预性研究。这代表了100% 从2017年到2021年，IIT（干预性）增加， 2017年至2021年的干预性IIT。此外，由于有意向人工智能社区推广， 在整个资助周期内，参与干预性试验的AI比例从4.4%增加到6.2%。