Clinical Protocol and Data Management (CPDM)

University Of Arizona, Tucson AZ

Investigators

Linked publications, trials & patents

Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM): ABSTRACT Part I: Clinical Protocol and Data Management (CPDM). Clinical research at the University of Arizona Cancer Center (UACC) is supported by the UACC Clinical Trials Office (CTO), which functions as the UACC Clinical and Protocol Data Management (CPDM) resource. The CTO staffing includes 79 FTEs to support UACC investigators conducting both interventional and non-interventional cancer clinical trials. The CTO supports Institutional, National Clinical Trials Network, Externally Peer-Reviewed, and Industry-sponsored clinical trials, and provides comprehensive services for the entire trial lifecycle, including regulatory support, data management, clinical research coordination, research nursing, training and education, and technology services. The CTO uses a centralized clinical trials management system, OnCore, to manage protocol conduct and to provide reports and performance metrics to the Cancer Center leadership. These metrics facilitate oversight and strategic planning and support ongoing process improvement and training needs. In the current project period, the CTO oversaw the activation of 327 interventional trials and 23 non-interventional trials. In the same period, the CTO supported the accrual of 6,116 participants to interventional trials, 1,259 to interventional treatment trials, and an additional 4,857 to non-interventional trials. This included the activation of 71 new trials and the recruitment of 3,535 participants during the 2020 COVID-19 period (2,835 to interventional accruals of which 342 were to interventional treatment trials and 700 to non-interventional trials). Part II: Data and Safety Monitoring (DSM). All interventional trials are required to include a DSM plan. For UACC-led interventional investigator-initiated trials (IITs), UACC’s DSM Board (DSMB) approves and executes the DSM plan by performing risk-based monitoring to ensure the highest levels of patient safety under an NCI- approved DMSB charter. In 2020, DSMB conducted 91 reviews that encompassed 48 serious adverse events across 15 trials. There were no findings that prompted an audit or trial suspension. Part III: Inclusion of Women and Minorities in Clinical Research. UACC actively promotes the recruitment of women and minorities. In the current review period, 3,153 women and 2,780 members of underrepresented minorities participated in clinical trials. In 2020, among the 2,835 individuals enrolled on interventional studies, 54% were female, 35% identified as an ethnic minority (Hispanic), and 11% identified as a racial minority. As a major new initiative, UACC is launching its Arizona Clinical Trials Network (ACTN) to improve clinical trial access to underrepresented populations across the Catchment Area and the entire state. Part IV: Inclusion of Individuals Across the Lifespan in Clinical Research. UACC complies with NIH policy on the inclusion of individuals across the lifespan in research. In the review period, 46 participants under the age of 20 and 651 over the age of 65 were enrolled on interventional treatment trials.