Clinical Protocol and Data Management

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ABSTRACT Overview: The Clinical Protocol and Data Management (CPDM) provides central administration and oversight functions for coordinating, facilitating, and reporting on clinical and population sciences trials across the UCCC clinical sites serving the catchment. The Data Safety and Monitoring Committee (DSMC) provides a robust structure for auditing clinical trials across the UCCC partner sites. DSMC's oversight is prioritized for high-risk Phase I and Phase II protocols. Accomplishments: Since 2016, the CPDM substantially improved clinical research support as follows: 1) Investigator-initiated trial (IIT) support leading to a 411% increase in IIT accruals from 2017-2020 compared to the previous similar period of 2013-2016; 2) Development of the Oncology Clinical Research Support Team (OCRST). OCRST provides centralized SOP development, staff and investigator training, multi-site coordination, and streamlining of processes for the successful implementation of clinical research protocols across the network; 3) Expansion of the Front Range Clinical Trials Network (FRCTN) provides clinical trial access to the population of Colorado. The inclusion of 5 UCHealth System clinical research sites in the FRCTN presents an enormous opportunity for clinical and population health research given the size and diversity of the socioeconomic demographics of the population and its rural/urban mix; 4) CPDM and UCHealth implemented the Via Oncology Pathways across the UCHealth system with clinical trials built into the pathways to ensure awareness and access to UCCC clinical trials across the catchment area. Quality Control and Training: The CPDM initiated an educational curriculum to provide a cohesive and relevant training structure to new staff and faculty and ongoing education to ensure those involved in the conduct of clinical investigation remain knowledgeable of policies and regulations. A new curriculum was developed that utilizes educational resources within the UCCC, UCAMC, the Colorado Clinical and Translational Sciences Institute (CCTSI, UL1TR001082) and enhanced by feedback received from trial audits. Trials and Catchment Area Demographics: The CPDM oversees an annual average of 527 clinical research studies. In FY2020, 608 patients were accrued to intervention-treatment studies. Patients seen at UCCC come from all 64 Colorado counties. Based on data from 2020, patient accruals were consistent with the state cancer demographics. UCCC has a plan to increase Hispanic enrollment to at least 10% and improve clinical trial access to the population at large. Taken together, these data demonstrate substantial progress in the CPDM and further demonstrate the UCCC's commitment to patients with cancer.