Clinical Protocol and Data Management

PROJECT SUMMARY CLINICAL PROTOCOL & DATA MANAGEMENT Clinical Protocol & Data Management (CPDM) provides comprehensive support for Moffitt Cancer Center (Moffitt) investigators that facilitate development and testing of new treatments, prevention strategies, supportive care, diagnostics, and biomarkers to translate them to the point of patient care. CPDM provides support through a talented centralized team that oversees the design, development, and conduct of interventional and observational trials; trial safety and compliance; data quality; personnel education; and appropriate accrual of women, minorities, and persons across the lifespan. CPDM activities are organized into four Specific Aims: Aim 1: To support investigators in development, implementation, and conduct of innovative cancer clinical studies, with a particular emphasis on investigator-initiated trials (IITs) Aim 2: To ensure safety and compliance through timely monitoring, audits, and committee oversight Aim 3: To provide comprehensive clinical research training and education, along with ongoing quality assurance, to meet the highest standards of research data and study patient care Aim 4: To facilitate appropriate inclusion of women, minorities, persons across the lifespan, and other underserved populations in clinical research studies Progress has included accruing 16,321 patients to interventional trials and 5,716 to treatment trials, representing a 38% increase in total trial interventional accruals since the previous reporting period. As a result of a 36-point clinical research action development plan, treatment accruals increased by 25% in FY2020 as compared to FY2015. Safety and compliance for these trials is overseen by the Protocol Monitoring Committees and is coordinated by the CPDM team under a revised NCI-approved Data & Safety Monitoring Plan. Moffitt has diligently worked to increase accruals of women, minorities, and persons across the lifespan through its Underserved Population Clinical Research Committee by: 1) establishing a committee called Reaching & Engaging Special Populations to Expand Clinical Trials (RESPECT); 2) increasing outreach and clinical research education events in underserved communities; and 3) establishing Moffitt-led trials at affiliate sites. These efforts resulted in Hispanic/LatinX accrual of 39.3% interventional and 7.8% treatment and African American/Black accrual of 6.3% interventional and 5.9% treatment, with plans to further increase inclusion. During the reporting period, 48% of patients accrued were women, which is similar to patients seen at Moffitt. Moffitt primarily serves adult patients. Age at time of accrual ranged from 18 – 94 (with 52% among being populations >65), ensuring that individuals across the lifespan participate in clinical trials at Moffitt. Overall, CPDM supports Members engaging in high impact clinical research by providing key compliance, coordination, and clinical outreach services throughout the trial lifecycle, from protocol development to closeout, ensuring the conduct of rigorous and innovative interventional and observational trials that benefit patients in our catchment area and beyond.