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Enhancing Adverse Event Identification and Management in Early-Phase Oncology Clinical Trials: The Emerging Role of

Sheena Charles1

  • 1From The University of Texas MD Anderson Cancer Center, Houston, Texas.

Journal of the Advanced Practitioner in Oncology
|December 5, 2025
PubMed
Abstract

Insights

Advanced practice providers (APPs) are crucial for managing adverse events (AEs) in early-phase oncology clinical trials (EPOCT). Their involvement improves AE reporting and patient outcomes, though standardized training and comparative studies are needed.

Area of Science:

  • Oncology
  • Clinical Trials
  • Patient Safety

Background:

  • Adverse events (AEs) pose significant risks in early-phase oncology clinical trials (EPOCT) due to experimental therapies.
  • Effective AE identification and management are vital for patient safety, trial success, and scientific advancement.
  • Advanced practice providers (APPs) are integral to AE detection and management, bridging clinical care and research, yet their full impact in EPOCT is not fully understood.

Purpose of the Study:

  • To review the literature on AE identification, reporting, and management within EPOCT.
  • To explore the specific role and impact of APPs in managing AEs during EPOCT.
  • To emphasize the influence of APPs on patient outcomes, clinical trial efficiency, and oncology research.

Main Methods:

  • Systematic literature search conducted from 2020 to 2025 across multiple databases.
  • Inclusion criteria focused on studies related to AE management in EPOCT, patient-reported outcomes (PROs), and APP roles.
  • Exclusion criteria targeted studies not relevant to oncology, AE management, or healthcare providers.

Main Results:

  • AE reporting shows variability; electronic PRO tools enhance data capture timeliness and accuracy.
  • APPs significantly contribute to outpatient AE management, reducing emergency visits and improving treatment adherence.
  • Challenges include underreporting with clinician tools, inconsistent APP training, and limited data comparing APP-led to physician-led AE management.

Conclusions:

  • APPs are essential for improving AE reporting and optimizing clinical trial processes.
  • Future research should prioritize standardizing APP training programs.
  • Comparative studies evaluating the efficacy of APP-led AE management are recommended.

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