Clinical Protocol and Data Management

临床方案和数据管理（CPDM）-摘要 Karmanos癌症研究所临床试验办公室（CTO）作为提供CPDM的集中资源， 为癌症中心提供服务和支持，最优先考虑的是参与患者的安全。 CTO提供从方案构思到启动的全面监管支持，包括联络 并与所有适用的机构审查委员会（IRB）和申办者进行沟通， 临床试验活动的启动和完成，IRB的所有批准和审查流程， 研究性新药（IND）支持，通过NCI临床试验报告计划注册新试验 （CTRP）以及ClinicalTrials. gov的适当注册和结果报告。 通过向KCI提供集中的、经过培训的数据管理和研究护士支持，优化应计费用 医生和临床支持人员。CTO与多个共享资源接口， 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，制药商发起和行业赞助 协议. KCI/WSU是NCTN（UG 1CA 233163）下的主要学术参与站点。有效的质量 由CTO提供控制和培训，以确保符合数据和安全性监测计划 （DSMP）。这包括对可行性审查和业务的协调和行政支持 委员会（FROC）、方案审查和监查委员会（PRMC）、数据和安全性监查 委员会（DSMC）和质量保证委员会（QAC）。 在本赠款期间，首席技术官工作人员的人数从108.85人增加到154.45人， CPDM服务支持超过500个活动协议在任何时候。提供服务的网络站点数量 临床试验增加了33%，导致KCI网络的干预性试验应计费用增加了6.8倍 研究中心（2015年94个，2019年641个）。强大的网络站点应计利润导致NRG领导学术的增加 参与研究中心（LAPS）的试验累积排名为2019年的第3位。努力减少方案激活 导致中位激活时间从2017年的213天减少到2017年11月的75天，减少了2.8倍。 2019.肯尼亚国际商会支持多方面的积极努力，以促进征聘妇女和少数民族。这些 这些努力使少数民族和妇女在目前的干预性试验中获得了特殊的登记， 2019年，少数族裔的应计比例为24.2%，妇女的应计比例为58.1%。KCI合作伙伴 密歇根州儿童医院（CHM），以促进儿科临床试验。儿科癌症专家 CHM作为儿童肿瘤学小组（COG）的成员机构积极参与（U10 CA 180886）。 CTO支持从儿童/青少年到老年人的整个生命周期内参与者的稳健累积。

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.