Clinical Protocol and Data Management

临床方案和数据管理(CPDM).摘要 卡马诺斯癌症研究所临床试验办公室(CTO)是提供CPDM的集中资源 对癌症中心的服务和支持，最优先的是参与其中的患者的安全。 CTO提供从协议构思到激活的全面监管支持，包括联络 并与所有适用的机构审查委员会(IRBs)和赞助者进行沟通，以促进及时 启动和完成临床试验活动，以及与IRB的所有批准和审查过程； 研究新药(IND)支持，向NCI临床试验报告计划注册新试验 (CTRP)，并向ClinicalTrials.gov进行适当的注册和结果报告。CPDM服务促进和 通过为KCI提供集中的、经过培训的数据管理和研究护士支持来优化应计 医生和临床支持人员。CTO与多个共享资源对接，以促进和 加强协作，改进流程，确保高效和有效地利用资源。《临床》 试验管理系统OnCore®用于管理所有临床试验要求。CTO支持 国家临床试验网络，NCI资助的同行评审，研究人员发起，行业赞助 协议。KCI/WSU是NCTN(UG1CA233163)下的主要学术参与站点。有效质量 控制和培训由首席技术官提供，以确保遵守数据和安全监控计划 (Dsmp)。这包括对可行性审查和业务的协调和行政支持 数据和安全监测委员会(FROC)、礼宾审查和监测委员会(PRMC) 和质量保证委员会(QAC)。 在本批款所述期间，首席技术官的工作人员人数从108.85人增加到154.45人，提供 CPDM服务，可同时支持500多个活动协议。提供的网络站点数量 临床试验增加了33%，导致KCI Network的介入试验收益增加了6.8倍 网站(2015年为94个，2019年为641个)。强大的网络站点收益导致NRG领先学术研究的增加 2019年参与站点(LAPS)试用累计排名升至第3位。减少协议激活的努力 次数导致激活时间中值从2017年11月的213天减少到75天，减少了2.8倍 2019年。KCI支持多种积极主动的努力，促进招募妇女和少数群体。这些 努力的结果是，在目前的情况下，少数民族和妇女例外地参加了干预性试验 赠款期间，少数民族应计24.2%，妇女2019年应计58.1%。KCI与 密歇根儿童医院(CHM)促进儿科临床试验的收益。儿科癌症专家 在CHM，作为儿童肿瘤学小组(COG)(U10CA180886)的成员机构积极参与。 CTO支持参与者在从儿童/青少年到老年人的整个生命周期内获得强劲的应计利润。

CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) - ABSTRACT The Karmanos Cancer Institute Clinical Trials Office (CTO) serves as a centralized resource providing CPDM services and support to the Cancer Center with the highest priority being the safety of participating patients. The CTO provides comprehensive regulatory support from protocol conception to activation, including liaison and communication with the all applicable Institutional Review Boards (IRBs) and sponsors to facilitate timely initiation and completion of clinical trial activities, all approval and review processes with the IRB, Investigational New Drug (IND) support, registration of new trials with NCI Clinical Trials Reporting Program (CTRP) and appropriate registration and results reporting with ClinicalTrials.gov. CPDM services facilitate and optimize accrual by providing centralized and trained data management and research nurse support to KCI physicians and clinical support staff. The CTO interfaces with several Shared Resources to facilitate and enhance collaboration, improve processes and ensure efficient and effective use of resources. The Clinical Trial Management System OnCore® is utilized to administer all clinical trial requirements. The CTO supports National Clinical Trials Network, NCI-funded peer reviewed, investigator-initiated, and industry sponsored protocols. KCI/WSU is a Lead Academic Participating Site under the NCTN (UG1CA233163). Effective quality control and training is provided by the CTO to ensure compliance to the Data and Safety Monitoring Plan (DSMP). This includes coordination and administrative support to the Feasibility Review and Operations Committee (FROC), Protocol Review and Monitoring Committee (PRMC), the Data and Safety Monitoring Committee (DSMC) and the Quality Assurance Committee (QAC). During the current grant period the number of CTO staff increased from 108.85 to 154.45 FTE, providing CPDM services in support of over 500 active protocols at any one time. The number of Network sites offering clinical trials increased by 33% resulting in a 6.8-fold increase in accruals to interventional trials at KCI Network sites (94 in 2015 to 641 in 2019). Strong Network site accruals led to an increase in NRG Lead Academic Participating Sites (LAPS) trial accrual ranking to #3 for 2019. Efforts toward reduction of protocol activation times led to a 2.8-fold decrease in median activation time from 213 days in 2017 to 75 days in November of 2019. KCI supports multiple, proactive efforts to promote the recruitment of women and minorities. These efforts have resulted in exceptional enrollment of minorities and women to interventional trials over the current grant period with 24.2% accrual of minorities and 58.1% accrual of women in 2019. KCI partners with Children’s Hospital of Michigan (CHM) to facilitate pediatric accrual to clinical trials. Pediatric cancer specialists at CHM actively participate as a member institution of the Children’s Oncology Group (COG) (U10CA180886). The CTO supports robust accrual of participants across the lifespan from pediatric/adolescents to older adults.