Clinical Protocol and Data Management

临床方案和数据管理：总结

CLINICAL PROTOCOL & DATA MANAGEMENT: SUMMARY Part I: Clinical Protocol & Data Management (CPDM). The Clinical Trials Office (CTO) at the Medical University of South Carolina (MUSC) Hollings Cancer Center (HCC) is comprised of 65.5 FTEs who provide centralized research support services to cancer center investigators. These services include comprehensive regulatory support from protocol conception to activation, Investigational New Drug support, registration of new trials, and results reporting with ClinicalTrials.gov. The CTO also optimizes accrual to externally peer- reviewed, investigator-initiated, National Clinical Trials Network, and industrial sponsored trials by providing a centralized core of trained clinical research coordinators and data managers to cancer center investiga- tors. Research coordination and protocol compliance is enhanced through fostering of investigator-patient- CTO interaction, collaboration, and teamwork. The CTO actively assesses protocol and regulatory compli- ance and monitors data accuracy and timeliness. As the central data repository of all oncology-related trial activities, the CTO provides comprehensive reports and performance metrics to the cancer center leadership for proper oversight and strategic planning including the development of training and education initiatives for both clinical research staff and investigators and other process improvement endeavors. In 2017 alone, the CTO reported the recruitment of 1,520 individuals into all clinical research studies within the HCC (1,266 interventional and 254 non-interventional accruals) and has facilitated the activation of more than 83 studies, including 19 institutional and externally peer-reviewed studies. Part II: Data & Safety Monitoring (DSM). DSM is required for all interventional studies. For cancer center investigator-initiated studies, the center has established its own Data & Safety Monitoring Committee (DSMC), which performs risk-based monitoring to ensure the highest levels of patient safety. Effective qual- ity control functions are also instituted to ensure the highest level of protocol compliance according to the HCC’s NCI-approved Data & Safety Monitoring Plan (DSMP). In 2017, the DSMC monitored 14 studies, which included the review of 18 audits, 14 progress reports, and 70 serious adverse events. Part III: Inclusion of Women and Minorities in Research. The HCC maintains and supports multiple, proactive efforts to promote the recruitment of women and minorities. In 2017, among the 1,520 individu- als enrolled onto all studies, 50% were women and 33% represented ethnic and racial minorities. Part IV: Inclusion of Children in Research. The HCC supports the NIH policy on the inclusion of children in research. The HCC is an active member of the NCTN Children’s Oncology Group and several other na- tional pediatric oncology trial consortia. In 2017, the CTO reported the recruitment of 53 children into all clinical research studies within the HCC (22 interventional and 31 non-interventional accruals).