Large Language Models for World Health Organization–Uppsala Monitoring Centre Drug–Adverse Event Causality Assessment Using Food and Drug Administration Adverse Event Reporting System Cases: Comparative Performance Study - Scorecard - MDSpire

Large Language Models for World Health Organization–Uppsala Monitoring Centre Drug–Adverse Event Causality Assessment Using Food and Drug Administration Adverse Event Reporting System Cases: Comparative Performance Study

  • By

  • Young Mi Ha

  • Minjung Kim

  • YoungIn Bang

  • Daejin Choi

  • Jae Hyun Kim

  • Sandy Jeong Rhie

  • Yoshihiro Noguchi

  • Myeong Gyu Kim

  • July 8, 2026

  • 0 min

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Clinical Scorecard: Evaluation of Large Language Models for Assessing Drug-Adverse Event Causality in WHO-Uppsala Monitoring Centre Data Using FDA Adverse Event Reporting System Cases: A Comparative Analysis

At a Glance

CategoryDetail
ConditionDrug-Adverse Event Causality Assessment
Key MechanismsUtilization of large language models for analyzing spontaneous adverse event reports.
Target PopulationPatients with reported adverse drug reactions.
Care SettingPostmarketing pharmacovigilance

Key Highlights

  • Causality assessment is essential for signal detection and patient safety.
  • WHO-UMC system is widely used but relies on expert interpretation.
  • Large language models may enhance the efficiency of causality assessments.
  • Study evaluates multiple LLM configurations and prompt engineering strategies.
  • Internal consistency of LLM outputs is analyzed across repeated assessments.

Guideline-Based Recommendations

Diagnosis

  • Utilize structured analytic cases for drug-AE causality assessment.

Management

  • Incorporate LLMs to support expert judgment in causality assessments.

Monitoring & Follow-up

  • Assess the performance of LLMs using quantitative agreement metrics.

Risks

  • Consider interrater variability and subjectivity in expert-driven assessments.

Patient & Prescribing Data

Patients with adverse drug reactions reported in FAERS.

Causality assessments require detailed clinical information and structured data.

Clinical Best Practices

  • Implement standardized criteria for causality assessment.
  • Ensure comprehensive data extraction from adverse event reports.
  • Utilize expert consensus as a reference standard for evaluation.

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