CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) Part I: Clinical Research Support (CRS). CRS includes 65 FTEs who provide centralized support for the conduct of cancer-related clinical research on behalf of the all Consortium institutions. The integrated CRS provides the infrastructure and processes to efficiently and effectively support over 176 Consortium investigators on all cancer clinical research studies and serves as the central repository of clinical research information. In FY 2018, CRS reported the recruitment of 10,716 individuals onto all clinical research studies (5,424 interventional and 5,292 non-interventional accruals) and facilitated activation of 180 studies (150 interventional), including 66 institutional and externally peer-reviewed studies. Part II: Data and Safety Monitoring (DSM). DSM is required for all interventional studies. For investigator-initiated studies, a well-established internal Data and Safety Monitoring Committee (DSMC) performs risk-based monitoring to ensure the highest levels of patient safety. In addition, effective quality control functions promote protocol compliance in accordance with sponsor requirements and the NCI- approved Consortium Data Safety Monitoring Plan (DSMP). In FY 2018, the DSMC monitored 118 studies, which included the review of 58 reports from study-specific DSMBs. Part III: Inclusion of Women and Minorities in Research. The Consortium leads multiple, proactive efforts to promote the recruitment of women and minorities. In FY 2018, among the 5,424 individuals enrolled onto interventional studies, 61% were women and enrollments consisted of 10% ethnic Hispanics and 23% non-White racial minorities, which compares favorably to catchment area demographics of 50% women, 10% Hispanic, and 24% non-White racial minorities. Part IV: Inclusion of Children in Research. The Consortium supports the NIH policy on the inclusion of children in research. The Consortium is an active member of the National Clinical Trials Network (NCTN) Children?s Oncology Group and several other national pediatric oncology trial consortia. Enhancements to our Children?s clinical research infrastructure have supported significant growth in Consortium enrollments. In FY 2018, 153 of the 286 (54%) newly registered pediatric patients enrolled on an interventional treatment trial compared to 85 of 240 (35%) in FY 2014. An additional 296 children were accrued to interventional non-treatment trials in FY 2018, up from 195 in FY 2014.
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