Clinical Protocol and Data Management

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CLINICAL PROTOCOL AND DATA MANAGEMENT: ABSTRACT The Clinical Protocol and Data Management (CPDM) component of the University of Florida Health Cancer Center (UFHCC) provides comprehensive resources and quality control for the efficient conduct of clinical cancer research relevant to our catchment area (CA), inclusive of efforts to address minorities, women, and individuals across the lifespan. The CPDM is overseen by George (CTHR), Associate Director for Clinical Research, and implemented by the UFHCC Clinical Research Office (CRO). UFHCC leadership and staff support clinical research addressing the needs of the UFHCC CA, with an emphasis on access to novel therapies arising from UFHCC research programs. The CRO facilitates the efficient conduct of high-quality clinical research through centralized management, reporting, and quality assurance functions. The CRO offers UFHCC investigators the infrastructure to manage a full range of investigator-initiated trials (IITs), external peer-reviewed, NCI sponsored, and industry trials, while also facilitating and tracking non-interventional studies. The CRO meets the needs of UFHCC members by supporting protocol development, activation, regulatory compliance, participant screening and recruitment, investigational pharmacy interactions, clinical research coordination, data abstraction, information dissemination, and interactions with sponsors and regulatory bodies. The CRO also provides centralized education and training to augment data integrity and participant safety. The office administers the UFHCC Data and Safety Monitoring Plan that delineates the structure and responsibilities of the Data Integrity and Safety Committee which reviews and assures the safe conduct of UFHCC clinical research. The UFHCC research portfolio emphasizes IITs, NCI sponsored studies, and other early phase treatment trials focusing on refractory diseases, to address the disproportionate number of advanced cancer diagnoses in our CA. From 2016 to 2021, the number of active UFHCC IITs increased by 63% from 24 to 39 while the number of actively accruing interventional protocols of all types, particularly treatment, screening, and supportive care, rose by 19% from 162 to 192. Consistent with UFHCC priorities to support NCI sponsored trials, UF is now a voting main member of NRG Oncology, a full member of the Children's Oncology Group, and currently the only non-NCI- Designated center member of the ETCTN. In 2016, UFHCC accrued 515 participants to interventional cancer- relevant clinical trials with 70% of those participants enrolling to IITs (23% on treatment IITs). With an increased emphasis on interventional protocols and more effective patient screening, year over year increases in enrollment occurred leading up to the pandemic. In 2021, there were 1,748 (up 3.4-fold since 2016) interventional accruals (91% on UFHCC IITs), including 299 treatment accruals (up 2.2-fold since 2016; 59% on IITs). While there were fewer treatment accruals due to the significant impact of COVID-19 in Florida, the UFHCC anticipates recovery of treatment accruals with expansion of the clinical trial portfolio, enhanced participant screening resources, and strengthened collaboration with the Office of Community Outreach and Engagement.