Clinical Protocol and Data Management

Fred Hutchinson Cancer Center, Seattle WA

Investigators

Linked publications & trials

Abstract

PROJECT SUMMARY Part I: Clinical Research Support (CRS). CRS includes 213 FTEs who provide centralized support for the conduct of cancer-related clinical research across the Fred Hutch/University of Washington/Seattle Children’s Cancer Consortium (Consortium). The integrated CRS provides the oversight functions and management infrastructure to effectively support over 202 Consortium investigators on active cancer clinical research studies and serves as the central repository of clinical research protocols and data. In FY2023, CRS enrolled 8,029 individuals onto studies (3,138 interventional and 4,891 non-interventional accruals) and facilitated activation of 189 studies (150 interventional), including 62 institutional and externally peer-reviewed studies. Part II: Data and Safety Monitoring (DSM). Consortium DSM is required for all prospective clinical research studies. A single DSM Committee (DSMC) performs risk-based monitoring for investigator-initiated studies to ensure the highest levels of patient safety across all Consortium sites. Effective quality assurance functions promote data integrity and protocol compliance in accordance with regulatory requirements and the Consortium DSM Plan (DSMP). In FY2023, the DSMC monitored 82 trials and CRS performed 136 quality assurance audits and monitoring visits. Part III: Participation of Women and Underserved Populations in Clinical Research. The Consortium leads a set of priority initiatives to ensure broad patient enrollment in clinical research. Initiatives encompass strategies to 1) understand barriers to trial participation and disparities in access, 2) provide infrastructure that promotes broad patient enrollment , and 3) implement accessible studies designed to address the cancer burden and inequities specific to our catchment area. In FY2023, among the 3,138 individuals enrolled onto interventional studies, 63% were women, 9% consisted of Hispanic participants, and 13% non-White participants, which compares favorably to catchment area cases of 52% women, 4% Hispanic, and 9% non-White populations. Part IV: Participation of Individuals Across the Lifespan in Clinical Research. The Consortium supports the NIH policy on the participation of children and older adults in clinical research. Expansion of the Consortium’s pediatric clinical trial infrastructure supports the evaluation and implementation of all applicable studies for participation of children. In FY2023, more than 25% of the 378 newly registered pediatric patients were enrolled on an interventional treatment trial. To improve representation of adults over 65, the Consortium employs strategies to mitigate access barriers and trial design exclusions specific to older adults. In FY2023, older adults represented 47% of the total adult accruals to interventional treatment trials.