Clinical Protocol and Data Management

ABSTRACT – CLINICAL PROTOCOL AND DATA MANAGEMENT The Clinical Research Central Office (CRCO) provides the centralized infrastructure for clinical research activities at the University of Wisconsin Carbone Cancer Center (UWCCC). The CRCO has 110 FTEs supporting 170 faculty PIs with an annual operating budget of $8.58M. The CCSG provides $311K annually (directs) of the total budget. Under the leadership of Center Director Dr. Howard Bailey (CPC) and Associate Director for Clinical Research, Dr. Kari Wisinski (DT), the CRCO has built upon the success of the prior efforts of expansion and centralization of the CRCO to increase accrual to treatment intervention studies and reduce activation timelines. The CRCO has central administration and services (fiscal, regulatory, informatics, compliance, education, etc.) and Disease-Oriented Teams (DOTs) to lead study activation and coordination. In 2021, the CRCO supported accrual of ~4,700 subjects to 538 research studies across the center. Of the 278 treatment intervention trials open during 2021, the sponsor breakdown was: 11 Externally peer-reviewed (4%), 107 Industrial (38%), 53 Institutional (19%), and 107 National (38%). UWCCC achieved an increase in accrual to treatment intervention studies from 319 in 2017 to 474 in 2021. Other key successes included expansion of a clinical trial navigation team and establishment of the UWCCC-led statewide Precision Medicine Molecular Tumor Board (PMMTB). These efforts facilitated high accrual of patients with catchment area priority cancers, rare tumors, and enrollment to genomically-driven studies. A new protocol intake management system, study activation huddles, and a dedicated activation team for NCI studies improved activation timelines by 23%. Staff turnover was stabilized with remote work options, supported by enhanced technology, and an improved career advancement pathway. The CRCO supports clinical research conducted on site, through multiple networks, including NCTN, ETCTN, and statewide and national investigator-initiated trial (IIT) networks (e.g. Wisconsin Oncology Network, Big Ten Cancer Research Consortium). Research informatics has expanded and CRCO leadership has optimized bi- directional communication strategies with DOT leaders and staff. CRCO leadership is actively engaged with the newly-established Oncology Service Council under Dr. Lee Wilke (TM), improving integration of research and clinical care. The QA/Compliance team executes the UWCCC DSMP, enacting risk-based monitoring, determined by study sponsorship and PRMC-adjudicated risk level. In collaboration with the UWCCC Community Outreach and Engagement Office Cancer Health Disparities Initiative, the CRCO has multiple new efforts to improve the accrual of underrepresented in medicine (URM) and rural individuals to clinical trials, including increased translation services; targeted media outreach; and dedicated community navigator support in DOTs. CRCO initiatives strive toward continued improvements in activation timelines, expanded access and accrual to genomically-driven, theranostic, and immunotherapy studies, especially for URM, and increased patient opportunities for tissue and data sharing in alignment with the UWCCC strategic plan.