Clinical Protocol and Data Management

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CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) ABSTRACT Clinical Protocol and Data Management (CPDM) is led by Dennis Slamon, MD, PhD (STT), UCLA Jonsson Comprehensive Cancer Center (JCCC) Associate Director for Clinical/Translational Research. CPDM functions reside fully within the JCCC Clinical Research Unit (CRU) under the direct authority of JCCC Director, Michael Teitell, MD, PhD (CMINT). The overarching objective of the CRU and its specific goals are to ensure access to clinical trials for oncology patients throughout the JCCC catchment area, Los Angeles County (LAC), and beyond, to further the science of clinical/translational oncology, and to provide new and effective FDA-approved therapies for widespread use. The CRU provides the necessary infrastructure to execute important and impactful clinical/translational studies. A strong relationship between the JCCC Director and UCLA research leadership enables the Center to establish the highest standards for oncology research. The CRU, led by Meghan Brennan, RN, MSN, ONP, PhD, JCCC Senior Director for Oncology Clinical Research, serves all UCLA/JCCC faculty conducting cancer-related clinical research. With 240 staff members supporting more than 60 principal investigators, the CRU oversees and manages more than 500 interventional trials annually. The CRU has centralized support functions for protocol development, regulatory submission to federal and institutional entities, study activation and execution, data and safety reporting, monitoring, auditing, and regulatory compliance. The JCCC, through the Data and Safety Monitoring Board (DSMB) and the CRU Office of Regulatory Compliance (ORC), provides oversight, data, and safety evaluations for interventional institutional trials. The JCCC ensures that all clinical trials design is with scientific integrity, having clinical and scientific relevance, addressing safety issues, and with performance according to state, federal, and institutional policies. Furthermore, the JCCC applies these standards to all clinical research, from both internal and external sponsors. Under Teitell, JCCC clinical/translational science and the CRU have grown and undergone transformational changes in a short period. Working together with Slamon and Brennan, Teitell quickly identified challenges and the potential for new opportunities influencing trial accrual performance and inclusion. Immediately, Teitell secured ~$1.8 M in additional institutional funding to develop and support new inclusion initiatives, update and augment the CRU infrastructure, and add more centralized programs for JCCC members. In the next project period, the expansion of JCCC clinical research activity with a focus on inclusion and accrual of women, minorities, children, and underserved populations in LAC and beyond are the highest priorities for Brennan and Slamon. The JCCC has invested substantially in a more comprehensive inclusion program through four new diversity initiatives in its catchment area, including the Burbank Gynecology Oncology Initiative, the Van Nuys Breast Cancer Program, the Olive View Medical Center (OVMC) Program, and Miller Children’s and Women’s Hospital Long Beach Partnership.