Clinical Protocol and Data Management (CPDM)

University Of California Los Angeles, Los Angeles CA

Investigators

Linked publications, trials & patents

Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) ABSTRACT Clinical research at the UCLA Jonsson Comprehensive Cancer Center (JCCC) occurs in UCLA hospitals and hospital-based clinics, 17 UCLA owned and operated Community Oncology Clinical Practices (COCPs), and multiple affiliate partners that accrue participants on behalf of the JCCC. Supporting JCCC clinical research is Clinical Protocol and Data Management (CPDM), with a dual role split into two independent, separate functional areas: (1) the JCCC Clinical Research Unit (CRU), responsible for research operations, under JCCC Associate Director for Clinical/Translational Research Dennis Slamon, MD, PhD (STT) and CRU Medical Director, Richard Finn, MD (STT); and (2) Data and Safety Monitoring (DSM), led by DSM Board (DSMB) Chair Sven de Vos, MD, PhD (CSCB). CRU infrastructure includes standard operating procedure (SOP) development and implementation, study activation and execution, quality assurance and quality control (QA/QC), and regulatory compliance with audit authority. The CRU provides investigator-initiated trial (IIT) development and execution services, data reporting and analysis, and standardized onboarding and training for faculty and staff. The JCCC clinical research program is sizeable, with an annual operating budget of $26.5M, ~225 FTE staff positions, and ~500 active interventional studies at any given time. From 2019 – 2023, the JCCC accrued an annual average of 17,704 participants on all studies, with an annual average of 12,959 to all interventional studies, and 969 to treatment trials. The CRU prioritizes access to trials for the wide variety of inhabitants of the Los Angeles County (LAC) catchment area and beyond. In 2023, 22.6% of individuals accrued to treatment trials identified as a minority and 43.3% were women. These percentages increase to 77.2% for minority and 54.2% for women accrual for all interventional trials in studies that include UCLA patients and prevention studies in LAC catchment area communities. Interventional studies accrued 35,432 pediatric, 431 adolescent and young adult (AYA), and 4,723 senior (65+) participants, with 132 pediatric, 339 AYA, and 2,455 seniors accrued to treatment trials. Separately, the JCCC DSMB has oversight and evaluates data and safety for institutional trials. From 2019 – 2023, the DSMB oversaw 103 JCCC investigator led interventional trials, including 28 multi-center studies and 10 gene medicine studies, and performed 236 audits and 333 monitoring visits. CPDM is guided by six Specific Aims: (1) To provide central infrastructure support for JCCC clinical research; (2) To prioritize trial enrollment across the full spectrum of the LAC population; (3) To oversee DSM for IITs with an effective internal auditing and monitoring program for safe and ethical conduct of JCCC clinical research; (4) To augment and evolve a rigorous education and training program for investigators and staff; (5) To hire and retain highly qualified trial staff with opportunities for growth and development; and (6) To host a clinical trials management system (OnCore), eRegulatory system (Florence eBinders), and a data-reporting infrastructure that support operations and data-driven decision making.