Clinical Protocol and Data Management

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ABSTRACT – CLINICAL PROTOCOL AND DATA MANAGEMENT The Clinical Research Central Office (CRCO) provides the centralized infrastructure for clinical research activities at the UW Carbone Cancer Center (UWCCC). The CRCO includes 87 FTEs who support 244 faculty PIs with an annual operating budget of $6.4M; annual CCSG provides $248K (directs) of the total CRCO budget. Under the leadership of Center Director Dr. Howard Bailey and Associate Director for Clinical Research, Dr. Ruth O’Regan (DT), UWCCC has significantly expanded and centralized the CRCO infrastructure, supported by a $2M investment (non-CCSG) by Dr. Bailey in new annual operating funds. Restructuring has yielded expertise and efficiencies in central administration, study coordination, patient care, regulatory, fiscal, informatics, quality assurance, billing compliance, and educational teams. In 2016, the CRCO supported accrual of 2,582 subjects to 257 research studies across the center. Of the 165 treatment intervention clinical trials in 2016, the sponsor breakdown was as follows: Externally peer reviewed (14 studies, or 8%), Industrial (54, or 33%), Institutional (23, or 14%), and National (74, or 45%). Promising early results of centralization include the reversal in 2016 of a 7-year decline in treatment intervention accrual, improvement in study activation metrics, and reduced CRCO staff turnover. The CRCO supports clinical research conducted on site, through NCTN and ETCTN, through our statewide IIT network Wisconsin Oncology Network (WON), and through our memberships in the Big Ten Cancer Research Consortium (BTCRC) and National Comprehensive Cancer Network (NCCN), with whom we are collaborating and developing new IITs. Research Informatics has expanded, led by a newly hired Assistant Director, Business Analyst, CTMS manager, and a revised OnCore® Support Team, increasing our eCRF development 7-fold. The QA/Compliance team executes our DSMP, enacting risk-based monitoring, determined by study sponsorship and PRMC-adjudicated risk level. Monitoring, auditing, and data quality and assurance reviews include Internal Audits, Compliance Reviews, and Review of SAE reporting. The CRCO has initiated multiple new initiatives to improve our accrual of women and minorities to clinical trials, including wider interactions with the UWCCC Cancer Health Disparities Initiative, increasing support of translator and multi- lingual consenting services, and targeted, multi-culturally appropriate media outreach efforts. The CRCO envisions continued expansion via vigorous support from the UWCCC and industry partnerships, enabling an increasing percentage of our patients’ access to innovative and impactful clinical trials.