Clinical Protocol and Data Management

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PROJECT SUMMARY/ABSTRACT The Markey Cancer Center (MCC) Clinical Protocol and Data Management (CPDM) facilitates all clinical cancer research at the University of Kentucky. CPDM’s Specific Aims are: 1) To provide comprehensive, centralized support for MCC clinical research activities; 2) To ensure the safety, compliance, and quality of all clinical cancer research performed at the center and MCC’s Research Network (MCCRN), in accordance with the Data Safety and Monitoring Plan and NCI requirements; 3) To integrate all efforts of the Cancer Center to provide clinical trial access to MCC’s patients, including women, minorities, underserved populations, and individuals across the lifespan; and 4) To provide ongoing education and training services for CPDM and MCCRN staff and faculty that enhance quality, diversity, consistency, and efficiency of teams and lead to increased engagement with MCC’s catchment population. The CPDM facilitates clinical research through the Clinical Research Office’s four units (72 FTEs), Protocol Development Teams (10 FTE), a Quality Assurance Program (5 FTE) and MCCRN (11 FTE), which provide centralized expertise for development, coordination, and execution of trials. In 2022, the Clinical Research Office managed 369 active trials—211 cooperative group, 113 industry sponsored, and 45 investigator-initiated (12 investigational new drug-enabling). MCC’s statewide infrastructure supports research referral and accrual within the catchment area. As the CPDM has matured, the center increased clinical research engagement to 98 of Kentucky’s 120 counties, with 18,753 total accruals (8,857 interventional; 9,896 non-interventional, 2018-2022). The Quality Assurance Program and Audit Committee function independently from other CPDM components to support education, safety and quality of trial conduct. All cancer trials are guided by MCC’s Data and Safety Monitoring Plan, which provides oversight in accordance with NCI CCSG requirements. The Data and Safety Monitoring Committee ensures patient safety and protocol compliance by staff and investigators. MCC leaders, investigators and staff promote the inclusion of women, minorities and Kentucky’s special population of Appalachia in clinical cancer research with impactful engagement of females (77% of all interventional accrual, 2018-2022) and Appalachian Kentuckians (61%). Enhanced efforts have increased minority trial participation to reflect this patient population, focusing on important cancer disparities such as lung and prostate cancers. In support of NIH policies, MCC strives for inclusion of individuals across the lifespan in clinical research. In 2021, 40% of therapeutic trial accruals were adults 65 or older, surpassing national averages. Cancer care for children is provided by one of two comprehensive pediatric oncology programs in the state. MCC is the first center in the region to offer germline testing to all pediatric oncology patients, supported by the Molecular Tumor Board interpretation of results.