Clinical Protocol and Data Management

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CLINICAL PROTOCOL AND DATA MANAGEMENT: ABSTRACT The Clinical Protocol and Data Management (CPDM) function provides comprehensive management and support services for clinical research activities at the Stephenson Cancer Center (SCC). CPDM services reside in the SCC’s Clinical Trials Office (CTO), which is comprised of ~200 FTEs and is under the direction of Kathleen Moore, MD (CT), the SCC Associate Director for Clinical Research. The CTO provides centralized and integrated research support services to all SCC members and clinical programs, including comprehensive regulatory support, data management, research coordination embedded in disease-site clinical programs, bioinformatics, quality assurance (auditing and data integrity), finance, and biospecimen acquisition and coordination. For investigator-initiated trials (IITs), a Protocol Support Unit (PSU) provides comprehensive support from protocol conception to activation, registration of new trials, and results reporting with ClinicalTrials.gov. The CTO supports a Data Safety and Monitoring Committee (DSMC) and written DSM Plan (approved by NCI). In addition, it works to ensure accrual to trials by women and children as well as minorities and other individuals in the SCC catchment area historically underrepresented in clinical research. During this grant cycle, several new initiatives were launched to enhance CTO functions, including: 1) implementation of a new CTMS (OnCore) expected to complete in Q3 2022; 2) creation and staffing of a strategic initiative and project management team; 3) creation and staffing of a new Education and Training team and a new Serious Adverse Event (SAE) team; and 4) expansion of the Quality Assurance team and the IIT PSU. In addition, CTO developed a clinical research component for the SCC’s new cellular therapies program inclusive of inpatient research support. Between 2017 and 2021, the CTO oversaw the recruitment, management and reporting of 11,121 individuals into all clinical research studies being conducted within SCC (3,095 interventional treatment, 4,216 interventional non-treatment, 3,810 non-interventional). During this time it facilitated the activation of 524 studies, including 71 institutional and externally peer-reviewed interventional studies. This represents a 100% increase in IITs (interventional) from 2017 to 2021 and a concomitant 40% increase in accruals to interventional IITs between 2017 and 2021. Further, due to intentional outreach to the AI community the percentage of AI enrolled to interventional trials increased from 4.4% to 6.2% across the grant cycle.