Clinical Protocol and Data Management

ABSTRACT - CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) The Clinical Protocol and Data Management (CPDM) of the O’Neal Comprehensive Cancer Center (O’Neal) maintains the highest standards of clinical investigation that are aligned with all university, state, and federal regulations, while assisting investigators in protocol development and all aspects related to clinical investigation. The CPDM is responsible for the following significant functions: 1) coordination, tracking, and reporting of all cancer clinical research activity undertaken at O’Neal, 2) continuous improvement of the clinical trial activation process, 3) ongoing education and training of clinicians and clinical research staff, 4) clinical trial data quality monitoring, 5) cancer clinical trial participant safety, and 6) actively ensuring all sections of the population represented in the O’Neal catchment area have the opportunity to be represented in cancer clinical trials. The O’Neal Clinical Trials Office (CTO) supports cancer treatment trials by providing regulatory services, financial management, recruitment of participants, clinical coordination, and data management. The CTO houses a specialized investigator-initiated trial (IIT) support team focused on protocol development, multi-site coordination, project management, and sponsor-level interactions with regulatory agencies. During the current CCSG cycle, there was an early decline in clinical trial activity. With establishment of new leadership in 2020 multiple interventions were put in place to increase overall accrual to treatment trials, foster the development of IITs, reduce overall time to protocol activation, and guide clinical trial activities to fit the cancer burden in Alabama. There were 12,861 accruals to interventional trials, including 2,261 accruals to treatment trials in the period, with a 13% increase in yearly accrual to treatment trials in 2020 when compared to 2019, in an upward trajectory that continues in 2021. The Data and Safety Monitoring Committee (DSMC) provides independent oversight of all clinical trials sponsored by O’Neal investigators to ensure safety of participants and integrity of data generated. The DSMC employs a risk-based classification of trials matched with different levels and scopes of audits and data review. During the current CCSG cycle, the DSMC oversaw an average of 88 trials at any given time, and performed 43 full audits/year. In coordination with our Office of Community Outreach and Engagement (OCOE), we have expanded efforts towards increased participation in O’Neal trials. Efforts to increase participation include the maintenance of a lay navigator clinical trial facilitation program, award of a CATCH-UP 2020 ETCTN administrative supplement, and establishment of strategic collaboration with health systems serving under-resourced populations. We maintain a strong commitment to expanding cancer clinical research to all patients across the lifespan with establishment of a Cancer and Aging program and an Adolescent and Young Adult Cancer program.