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.
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