Clinical Protocol & Data Management (CPDM)

Duke University, Durham NC

Investigators

Linked publications, trials & patents

Abstract

The Duke Cancer Institute (DCI) Clinical Protocol Data Management (CPDM) team resides in the Clinical Research Unit (CRU) and provides comprehensive protocol and data management services to DCI members including protocol development, research conduct, study monitoring, safety surveillance, education and training, and reporting cancer related clinical research. CPDM supports the clinical research and trial conduct of interventions designed to prevent, diagnose, and treat cancer, and improve the long-term outcomes for cancer survivors. The CRU mission is to provide infrastructure for centralized processes that allow facilitation, progress, quality assurance, safety and reporting of all cancer-related clinical protocols to support the DCI mission of providing access to novel and innovative therapies for all of our patients. Despite this grant period encompassing the challenges related to the COVID-19 pandemic, interventional accruals increased by 47% and therapeutic accruals increased by 10% compared to the prior grant period. Trial activation timelines also improved throughout this grant period, with a 25% improvement in time from PRMC submission to PRMC approval, 77% improvement in time from PRMC submission to institutional approval, and 38% improvement in total number of median work days from PRMC submission to open to accrual. These successes were due to continuous improvement initiatives to optimize processes and gain efficiencies, partnership with DCI Information Services to leverage technology throughout CRU operations, the establishment of a study startup team, and strategic staffing decisions to support multicenter investigator-initiated trials. Collaboration with the DCI Monitoring Team and the Safety Oversight Committee (SOC) ensures that the CRU conducts clinical trials in a safe and compliant manner. We designed and implemented robust training for CRU staff, particularly in the areas of representation in clinical trials, cultural sensitivity and competence, optimization of technology, and leadership. With our partners in research finance, the CPDM ensures CRU operations are fiscally responsible, allowing us to support our highest priority cancer clinical trials. The CPDM team works in partnership with the Associate Directors of Community Outreach and Engagement (Tomi Akinyemiju, PhD (CRDI)), which is integral to enhancing representative accruals through education, protocol design consultation, and patient navigation. Trial activation timelines also improved throughout this grant period, with a 25% improvement in time from PRMC submission to PRMC approval, 77% improvement in time from PRMC submission to institutional approval, and 38% improvement in total number of median work days from PRMC submission to open to accrual. These successes were due to continuous improvement initiatives to optimize processes and gain efficiencies, partnership with DCI Information Services to leverage technology throughout CRU operations, the establishment of a study startup team, and strategic staffing decisions to support multicenter investigator-initiated trials. Collaboration with the DCI Monitoring Team and the Safety Oversight Committee (SOC) ensures that the CRU conducts clinical trials in a safe and compliant manner. We designed and implemented robust training for CRU staff, particularly in the areas of representation in clinical trials, cultural sensitivity and competence, optimization of technology, and leadership. With our partners in research finance, the CPDM ensures CRU operations are fiscally responsible, allowing us to support our highest priority cancer clinical trials. The CPDM team works in partnership with the Associate Directors of Community Outreach and Engagement (Tomi Akinyemiju, PhD (CRDI)), which is integral to enhancing representative accruals through education, protocol design consultation, and patient navigation.