Clinical Protocol and Data Management

CLINICAL PROTOCOL AND DATA MANAGEMENT - ABSTRACT The Clinical Protocol and Data Management (CPDM) function at the University of Hawaiʻi Cancer Center (UHCC) is situated within the Clinical Trials Office (CTO). CPDM supplies the infrastructure and access to state-of-the-art clinical trials for Hawaiʻi’s community-based providers and their patients. Led by Medical Director Toshiaki Iwase MD, PhD, the CPDM oversees central management functions for coordinating, facilitating, and reporting on cancer clinical for our Center. These trials encompass national group, externally peer-reviewed, industry-sponsored, and investigator-initiated trials (IITs). Other vital components of CPDM include regulatory affairs, protocol administration and management, protocol information technology management via OnCore our Clinical Trials Management System, staff training, and investigator education and training activities. Disease Site Working Groups (DSWGs) function to curate research portfolios supported by CPDM that cater to our catchment area's needs, and our Patient Advocacy Council focuses on educating the community about clinical trials, facilitating community and patient engagement, and promoting enrollment in cancer trials. Data and Safety Monitoring (DSM) is complementary to CPDM. It provides the framework for the review of data and safety monitoring plans for all protocols and ensures ongoing monitoring of patient safety and data quality. The UHCC Compliance Office steers the quality assurance and audit functions of DSM. This office serves as the responsible entity for quality assurance for all clinical research activities across the entire UHCCsupported network, conducting internal audits and overseeing reports of external audits from NCORP Research Bases (National Groups) and industry sponsors. Lastly, UHCC is mainly focusing on populations in Hawaiʻi and the Pacific, such as Native Hawaiians and Pacific Islanders and heavily emphasizes the enrollment of participants across the lifespan in clinical research. UHCC has successfully enrolled pediatric cancer patients in its clinical trials. While less than 1% of Hawai‘i’s cancer patients are under 20 years old, 4.2% of all interventional clinical trial enrollees at UHCC were children in 2022.