Clinical Protocol and Data Management

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PROJECT SUMMARY/ABSTRACT Part I: Clinical Protocol and Data Management (CPDM). CPDM facilitates all clinical cancer research at the Markey Cancer Center (MCC) and is responsible for an increase to over 1,000 interventional accruals per year and 9,357 interventional accruals over the reporting period. The CPDM has 3 major components: the Clinical Research Office (CRO), the Quality Assurance (QA) Office and the MCC Data and Safety Monitoring Plan (DSMP). Oversight is provided by the Associate Director for Clinical Translation, Susanne Arnold, MD (DT), who supervises the CRO Medical Director (Jonathan Feddock, MD [DT]) and the Precision Medicine Center (PMC) Director (Jill Kolesar, PharmD, MS [DT]), assisted by the Associate Director for Administration (David M. Gosky, MA, MBA). The CRO consists of 4 operational units: Finance, Regulatory, Clinical and Precision Medicine, providing investigators with centralized expertise and support for the implementation, coordination and execution of cancer clinical trials. The Cancer Research Informatics Shared Resource Facility supports the CRO through centralized clinical trials management and reporting to the National Cancer Institute (NCI). The CRO staff focuses on MCC's mission, vision and values to support investigators in the highest quality clinical cancer research with adherence to all federal and state guidelines. Part II: Data and Safety Monitoring. All cancer clinical trials conducted by MCC investigators or the MCC Research Network include oversight of data and safety monitoring. The MCC DSMP, approved by the NCI in 2013 and revised annually, provides guidance for the conduct of all cancer clinical trials in accordance with the NCI CCSG requirements. The Data and Safety Monitoring Committee (DSMC) assures patient safety and protocol compliance by MCC investigators and staff, and has monitored 1,654 trials during the reporting period. The QA Office and the Audit Committee perform monitoring and auditing of trials, including 107 trials over the reporting period, as well as assisting in 9 successful external audits. Part III: Inclusion of Women and Minorities in Clinical Research. MCC leadership, investigators and staff are committed to the inclusion of women, all minorities and our National Institutes of Health-designated special population of Central Appalachia in cancer clinical trials. While many trials have genomic, histologic or stage-specific entry criteria, every effort is made toward inclusion, with a focus on clinical trials with high minority incidence such as breast cancer (African-American), hepatocellular carcinoma (Hispanic/Latino, African-American) and prostate cancer (African-American). Females represent over 60% of accruals to treatment interventions and 1,892 women were accrued to interventional protocols in 2016. Part IV: Inclusion of Children in Clinical Research. UK's Pediatric Oncology and Hematology Division has a broad portfolio of trials via the Children's Oncology Group and investigator-initiated trials, spanning common (leukemia/lymphoma, neuroblastoma, Wilms tumor, osteosarcoma) to rare pediatric cancers.