Clinical Protocol and Data Management

CLINICAL PROTOCOL AND DATA MANAGEMENT ABSTRACT Clinical Protocol and Data Management (CPDM) serves a critical role at Huntsman Cancer Institute (HCI) of overseeing the successful execution of clinical research. CPDM processes yield efficient and high-quality outcomes to support the Cancer Center in its mission to create and improve cancer treatments, with the ultimate goal to relieve the suffering of cancer patients. The leadership of CPDM has both administrative and clinical expertise to sustain a culture of exceptional clinical research, with clinical trials as the most important choice of treatment for patients at HCI. The largest centralized group within CPDM is the Clinical Trials Office (CTO, 129 FTEs), which has a well- defined mission to support interventional treatment trials at HCI. The primary goal of the CTO is to promote efficient completion of compliant clinical trials, while ensuring patient safety, study integrity, and streamlined study activation. The CTO provides robust regulatory, financial, clinical, and data coordination support to principal investigators in the HCI community. The CTO seeks a balanced portfolio serving our patient population and encompassing rare disease clinical trials. Currently, the CTO oversees approximately 390 active clinical trials, caring for more than 1,800 clinical trial participants. HCI conducts Data and Safety Monitoring (DSM) for all investigator-initiated clinical trials, commensurate with their level of risk and as defined in our National Cancer Institute-approved Data and Safety Monitoring Plan. Trials overseen include physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); and efficacy, effectiveness, and comparative trials (Phase III). HCI is committed to serving all residents of our catchment area, the State of Utah. We aim to provide exceptional care and access to the latest advances in cancer treatment through participation in clinical research. HCI maintains heightened awareness to ensure that all populations in our catchment area receive appropriate care and opportunities for clinical trials at our Center.