CLINICAL PROTOCOL AND DATA MANAGEMENT (Core-176) ABSTRACT Overview: The Clinical Protocol and Data Management (CPDM) provides central management and oversight functions for coordinating, facilitating and reporting on clinical and population sciences trials across the UCCC consortium which serve our catchment area of the State of Colorado. The CPDM is led by Thomas Flaig MD, Associate Director for Clinical Research and supported by Colleen Kellackey RN, Consortium Clinical Research Director. The UCCC Data and Safety Monitoring Plan (DSMP) was approved by the NCI in October, 2014. The Data Safety and Monitoring Committee (DSMC) provides a robust structure for auditing clinical trials across the consortium. DSMC's oversight is prioritized for high-risk Phase I and Phase II protocols. Accomplishments: Since 2011, the CPDM substantially improved clinical research support as follows: 1) CPDM led an institutional- wide effort to select and implement the OnCore commercial clinical trial management system (CTMS) integrated with the UCD clinical data repository (Health Data Compass). OnCore was activated July 2015; 2) CPDM leadership implemented an acuity tool to right-size the clinical research staff for the adult Cancer Clinical Trials Office (CCTO); 3) CPDM increased its support for institutional trials by adding staff; and the 4) the DSMC auditing capacity was increased by 2 auditors. Quality Control and Training: An education coordinator position was added to the CPDM. In addition to outlining and coordinating training and orientation for data managers, nurses and new faculty, the coordinator works closely with the DSMC to review trends from internal and external audits. Based on these findings, the coordinator works with the CPDM leadership to develop focused educational outreach to clinical investigators and recommends policy updates to improve the quality and compliance of clinical research. Trials and Catchment Area Demographics: The CPDM oversees an annual average of 382 clinical research studies. In FY2015 1,499 patients were accrued to intervention studies and 706 were accrued to intervention-treatment studies representing 18% of the analytic cases reported by UCH, CHCO and the VA. Patients accrued to clinical trials come from 61 of 64 Colorado counties. Based on data from 2015: 1) Although approximately half the cancer population is female, 58% of the accrued patients were female, representing a substantial increase from 2012 (49%) and 2) 3% and 5% of patient accruals were African American and Hispanic, respectively. UCCC continues to enroll women and African Americans in rates that are consistent with the cancer incidence in these specific populations and has a plan to increase Hispanic enrollment to at least 10%, consistent with the cancer incidence in the population. Taken together, these data demonstrate substantial progress in the CPDM and further demonstrate the UCCC's commitment and success in providing safe and equitable clinical investigative opportunities to Colorado's cancer patients.
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