Clinical Protocol and Data Management

University Of California At Davis, Davis CA

Investigators

Linked publications, trials & patents

Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT PROJECT SUMMARY/ABSTRACT The CPDM provides unified oversight and support for coordinating, facilitating, and reporting on clinical trials managed by the University of California Comprehensive Cancer Center. The CPDM research strategy is composed of four sections that describe the processes involved in conducting clinical trials uniformly and safely. Part I: Clinical Protocol and Data Management is managed by the Office of Clinical Research (OCR), which is led by Karen Kelly, MD (OCR Medical Director) and Ahmed Bayoumi, MD (OCR Executive Director). The OCR includes six units: operations, business, regulatory, clinical, data, and correlative lab thus providing Cancer Center investigators with centralized services to conduct clinical trials. The OCR staff work cohesively with the investigators to provide subjects with exceptional care such that toxicities are minimized, trial adherence is maintained, and data quality is achieved. Part II: Data and Safety Monitoring. All clinical trials conducted under UCDCCC include provisions for data and safety monitoring. The Data Safety and Monitoring Plan (DSMP) focuses on patient safety, protocol adherence, and data quality. In anticipation for the CCSG competitive renewal, the DSMP was revised and subsequently approved by the NCI in August 2020. Part III: Inclusion of Minorities and Women in Clinical Trials. The UCDCCC is dedicated to the inclusion of women and minorities in cancer clinical trials and complies with the NIH regulations on accrual of these populations. Entry criteria for cancer studies are disease, not gender or ethnicity specific. However, the Center has recruitment strategies specifically focused on women and minority populations who experience disparities, for example, liver cancer (Asian Americans and all populations of color), prostate cancer (African Americans and Hispanics/Latinos), and breast cancer (African Americans, Hispanics/Latinos, and Asian Americans). Part IV: Inclusion of Across the Lifespan in Clinical Trials. To ensure patients from all ages are recruited to trials, UCDCCC has intensified its plans to recruit pediatric patients and will begin raising awareness and developing recruitment plans to enroll patients > 64 years old.