Clinical Protocol and Data Management

Johns Hopkins University, Baltimore MD

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY/ABSTRACT 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 of which are stored and tracked through a centralized repository that contributes to the efficient flow of protocol- related data in a system-wide integrated approach. From 2016–2020, 8,234 accruals to interventional trials (7.5% increase over 2011–2015) were managed, representing 26% of our annual registry cases. Of the accruals, 68% were to therapeutic trials. CPDM QA group reviewed 108 studies with a total of 141 reviews, oversaw 100 Investigational New Drug applications, and provided ongoing education and guidance. The Coordinating Center managed 29 multisite trials with 132 external sites. The CRGs, led by faculty CRG Directors and Managers, unite research staff around their multidisciplinary disease focus to conduct clinical research. The CPDM supports committees that promote quality review, engage faculty and staff in operational efficiency, and lead forums that disseminate improvements. The CPDM provides various educational series, ad hoc sessions and onboarding for new faculty, fellows and staff. The CPDM administratively supports the independent Protocol Review and Monitoring System and the Safety Monitoring Committee. An institutional Data Safety Monitoring Board reviews all randomized clinical studies and high-risk institutional and externally peer-reviewed studies. Inclusion of women and minorities in SKCCC clinical trials remains a major focus of leadership and faculty members. The Assistant Director for Diversity and Inclusion works with the Office of Community Outreach and Engagement and the CPDM to collect and analyze accrual data, develop SOPs to improve accrual, and promote cultural humility in recruitment and retention practices. Minority inclusion consistently matches the diversity of the individuals seeking care at the SKCCC. An additional 193 African Americans participated in interventional trials compared to the prior five years. The inclusion of individuals across the life span in clinical research is an important commitment to our catchment area. Participation of children, underserved and aging cancer patients is apparent across our broad portfolio of clinical trials.