Quality-driven medical oversight in global oncology trials: Standardizing immune-related AE management to enhance patient safety.

Abstract

e23311 Background: Immune-based therapies have transformed the treatment landscape across multiple malignancies; however, they are associated with a distinct spectrum of immune-related adverse effects. If not adequately managed, these toxicities may affect multiple organ systems, resulting in treatment interruptions or discontinuation. In global oncology trials, variability in site-level operational practices may contribute to inconsistent immune-related adverse event (ir-AE) documentation and management, potentially impacting patient safety and data integrity. A standardized, quality-driven operational framework was implemented to support consistent identification, documentation, and oversight of irAEs across diverse trial settings. Methods: A retrospective analysis was conducted across four global oncology clinical trials evaluating immune-therapy–based regimens delivered under a standardized medical oversight framework. Predefined MedDRA preferred terms within the safety database, were used to identify irAEs. Adverse event severity was summarized using CTCAE grading. Patterns of AE grading consistency, treatment impact (dose interruption, delay, or discontinuation), and use of concomitant medications for irAE management, including corticosteroids and immunosuppressive agents, were assessed on aggregated data. Results: Evaluation of AE data identified delayed or inconsistent AE grading and recurring patterns in irAE documentation across the four trials. Analysis of trends of AE severity, treatment impact, and concomitant medication use, highlighted frequently observed and clinically complex irAEs. Review of aggregated safety data demonstrated variation in the timing of AE reporting and protocol deviation identification with a median 3-week difference in time to detection of underreported AEs and a 20% difference in time from protocol deviation occurrence to identification across studies. Pre-established irAE management guidelines, aligned with published consensus recommendations, were consistently applied across global trial sites. Conclusions: A structured, quality-driven medical oversight framework enhanced consistency in monitoring and reporting of irAEs across global oncology trials. Standardization of safety oversight enabled earlier identification of documentation issues, reduced variability in irAE management practices, and strengthened the reliability and integrity of safety data, supporting effective centralized medical oversight in immune-oncology clinical development.