Abstract
Background: Adverse events (AEs) are unintended, harmful effects that occur in clinical trials, particularly in early-phase oncology clinical trials (EPOCT), where the risk of adverse effects from experimental therapies is high. Effective AE identification and management are essential for ensuring patient safety, improving outcomes, and advancing research. Advanced practice providers (APPs) play a key role in detecting and managing AEs, serving as a bridge between clinical care and research. However, their full impact on EPOCT remains underexplored. Purpose: This integrative review examines existing literature on AE identification, reporting, and management in EPOCT. It explores the role of APPs in managing AEs, emphasizing their impact on patient outcomes, clinical trial efficiency, and oncology science. Methods: A systematic search of peer-reviewed literature from 2020 to 2025 was conducted using various databases. Inclusion criteria were studies addressing AE management in EPOCT, patient-reported outcomes (PROs), and APP roles. Studies unrelated to oncology, AE management, or health-care providers were excluded. Results: Findings highlight the variability in AE reporting and the growing utility of electronic PRO tools in capturing timely and accurate data. Advanced practice providers contribute significantly to outpatient AE management, reducing emergency visits and improving treatment adherence. However, challenges remain, including underreporting with clinician-based tools, lack of standardized APP training, and limited comparison to physician-led AE management. Conclusion: APPs serve as key players in enhancing AE reporting and improving clinical trial processes. Future research should focus on standardizing structured training programs for APPs and comparative studies assessing the effectiveness of APP-led care.
