National Cancer Institute 5P30CA006973-63

Clinical Protocol and Data Management

Award to Johns Hopkins University for Clinical Protocol and Data Management to support clinical research at Sidney Kimmel Comprehensive Cancer Center, enhancing trial management, compliance, and community engagement in cancer research.

Description

Clinical Protocol and Data Management (CPDM) provides centralized services to faculty and staff conducting clinical research at the Sidney Kimmel Comprehensive Cancer Center (SKCCC), fostering efficiency and regulatory compliance. The CPDM supports all SKCCC research sites and maintains over 100 standard operating procedures (SOPs). Comprising over 20 FTEs centrally and oversight of 184 Research Nurses/Coordinators within the Clinical Research Groups (CRGs), the CPDM works closely with the CRGs to manage a robust cancer clinical trial portfolio that prioritizes institutional and externally peer-reviewed trials, and complements the SKCCC patient catchment area. The CPDM has three operational sections, each supervised by a manager: Operations, Compliance, and the Coordinating Center. Administration of the CPDM is the responsibility of the CPDM Director and the Associate Director for Clinical Research. The Operations group supports 250 investigators and oversees 467 interventional and 296 non-interventional studies, all tracked through a centralized repository that facilitates efficient protocol-related data flow. From 2016–2020, 8,234 accruals to interventional trials were managed, representing 26% of annual registry cases, with 68% to therapeutic trials. The QA group reviewed 108 studies with 141 reviews, oversaw 100 Investigational New Drug applications, and provided ongoing education. The Coordinating Center managed 29 multisite trials with 132 external sites. The CRGs, led by faculty CRG Directors and Managers, focus on multidisciplinary disease areas to conduct clinical research. The CPDM supports committees that promote quality review, operational efficiency, and dissemination of improvements. Educational series, onboarding, and support for the Protocol Review and Monitoring System and Safety Monitoring Committee are provided. An institutional Data Safety Monitoring Board reviews all randomized and high-risk studies. Efforts to ensure SKCCC clinical trials participation reflects the community are ongoing, with a focus on inclusive enrollment across the lifespan, including children, understudied, and aging cancer patients.

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