Clinical Protocol & Data Management

CLINICAL PROTOCOL AND DATA MANAGEMENT – PROJECT SUMMARY/ABSTRACT The Cancer Center has a vibrant and effective Clinical Protocol and Data Management infrastructure, composed of the following key elements: 1. An oversight committee, the Clinical Trials Advancement Committee (CTAC), provides central oversight for all cancer-related clinical research. 2. A central office, the Office of Clinical Research (OCR), that provides support through: • Protocol Development Team for trial development and protocol writing of investigator initiated trials • Activation of new and maintenance of previously opened trials through regulatory submissions, budget development, and invoicing of co-operative group and industrial trials • Clinical research coordination and data management • Subject recruitment • NCI administrative functions 3. Disease-specific research teams that are involved in trial development, selection, prioritization, and implementation. 4. A Research and Clinical Trial Analytics support team that maintains a central location for cancer protocols, protocol-specific data, and protocol status. 5. The Clinical Research Optimization Committee (CROC) that facilitates the alignment of oncology clinical research and Health System operations. The committee helps develop processes and reviews infrastructure needed to support growth in oncology clinical trials. 6. Complex Trial Committee (CTC) that is responsible for reviewing any complex trials that may stress the clinical and research infrastructure or have special considerations. 7. Ancillary services (Investigational Drug Services Pharmacy (IDS Pharmacy), Emily Couric Clinical Cancer Center (ECCCC) Nurse Liaison, Biorepository and Tissue Research Facility (BTRF)) that facilitate initiation and conduct of trials. 8. UVACC Clinical Research Orientation, Training, and Quality Assurance Program that provides education, training, and quality assurance to oncology clinical research personnel Over the past five years, the UVACC has made great progress in accrual to both interventional and therapeutic trials. Between FY16 and FY20; the increase to interventional trials was 293% (including an increase of 494% to investigator-initiated interventional trials), and accrual to treatment trials increased 15%.