Serious Adverse Events in Oncology Trials: Novel Risk Assessment
and Management Approaches
Nitesh Prasad Sah
Fortis Healthcare Research Foundation, Gurugram, Haryana, Department of Clinical Research, Fortis
Flt. Lt. Rajan Dhall Hospital New Delhi-110070
Received: 19 March 2026; Accepted: 27 March 2026; Published: 14 April 2026
ABSTRACT
Serious adverse events (SAEs) remain a critical concern in oncology clinical trials, directly impacting patient
safety and the development of new therapies. With the growing use of targeted treatments and
immunotherapies, treatment-related toxicities have become more complex and less predictable than with
conventional chemotherapy. Traditional reactive approaches are increasingly inadequate, necessitating
proactive strategies for early identification and management of SAEs. Advances in artificial intelligence (AI)
and predictive analytics have enabled the early detection of adverse events and the identification of high-risk
patients (6,7,20). Additionally, decentralized trials and wearable technologies now allow continuous, real-
world patient monitoring (16). Despite these innovations, challenges such as data quality, algorithm
transparency, and evolving regulatory frameworks limit their widespread adoption. This review synthesizes
current knowledge on SAE risk factors, discusses monitoring and management strategies, and highlights
emerging technologies aimed at enhancing patient safety in oncology trials.
Keywords: Serious Adverse Events, Oncology Trials, Risk Assessment, Patient Safety, Pharmacovigilance,
Artificial Intelligence
INTRODUCTION
Clinical trials are essential for advancing cancer treatment but are frequently associated with a high incidence
of SAEs, due to both the toxicity of therapies and the vulnerable condition of patients (1,3). Factors such as
advanced age, comorbidities, prior treatments, and organ dysfunction further increase SAE risk (10). Different
categories of oncology therapies present distinct toxicity profiles: Chemotherapy (e.g., cisplatin, doxorubicin)
is commonly associated with bone marrow suppression and organ toxicity. Immune checkpoint inhibitors
(e.g., nivolumab, pembrolizumab) can trigger immune-related adverse events affecting multiple organs (4).
Targeted therapies (e.g., trastuzumab, imatinib) carry mechanism-specific risks, including cardiac or hepatic
complications (12).
Standardized reporting frameworks such as the Common Terminology Criteria for Adverse Events (CTCAE)
ensure consistency in grading and classifying toxicities (18). However, conventional trial designs face
challenges including complex protocols, delayed recruitment, and intensive monitoring requirements (5).
Emerging strategies, including AI-assisted tools and real-time patient monitoring, are being explored to
improve SAE management.
Objectives
To identify key risk factors contributing to SAEs in oncology trials.
To review current monitoring and management strategies.
To explore emerging technologies for enhancing patient safety.
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