Evidence map›Paper›PMID 40979379›Full record

ArticleFrontiers in drug safety and regulation2024

Assessing the performance of large language models in literature screening for pharmacovigilance: a comparative study.

Dan Li, Leihong Wu, Mingfeng Zhang, Svitlana Shpyleva, Ying-Chi Lin, Ho-Yin Huang, Ting Li, Joshua Xu

Abstract read
In one paragraph

Article in Frontiers in drug safety and regulation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Semantic Search of FDA Guidance Documents Using Generative AI.Therapeutic innovation & regulatory science · 2025
    Article
  9. Review
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Dan LiDivision of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, United States.
Leihong WuDivision of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, United States.
Mingfeng ZhangDivision of Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States.
Svitlana ShpylevaDivision of Biochemical Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, United States.
Ying-Chi LinSchool of Pharmacy, College of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan.
Ho-Yin HuangSchool of Pharmacy, College of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan.
Ting LiDivision of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, United States.
Joshua XuDivision of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pharmacovigilance plays a crucial role in ensuring the safety of pharmaceutical products. It involves the systematic monitoring of adverse events and the detection of potential safety concerns related to drugs. Manual literature screening for pharmacovigilance related articles is a labor-intensive and time-consuming task, requiring streamlined solutions to cope with the continuous growth of literature. The primary objective of this study is to assess the performance of Large Language Models (LLMs) in automating literature screening for pharmacovigilance, aiming to enhance the process by identifying relevant articles more effectively. This study represents a novel application of LLMs including OpenAI's GPT-3.5, GPT-4, and Anthropic's Claude2, in the field of pharmacovigilance, evaluating their ability to categorize medical publications as relevant or irrelevant for safety signal reviews. Our analysis encompassed N-shot learning, chain-of-thought reasoning, and evaluating metrics, with a focus on factors impacting accuracy. The findings highlight the promising potential of LLMs in literature screening, achieving a reproducibility of 93%, sensitivity of 97%, and specificity of 67% showcasing notable strengths in terms of reproducibility and sensitivity, although with moderate specificity. Notably, performance improved when models were provided examples consisting of abstracts, labels, and corresponding reasoning explanations. Moreover, our exploration identified several potential contributing factors influencing prediction outcomes. These factors encompassed the choice of key words and prompts, the balance of the examples, and variations in reasoning explanations. By configuring advanced LLMs for efficient screening of extensive literature databases, this study underscores the transformative potential of these models in drug safety monitoring. Furthermore, these insights gained from this study can inform the development of automated systems for pharmacovigilance, contributing to the ongoing efforts to ensure the safety and efficacy of pharmacovigilance products.

Indexed as

artificial intelligencelarge language modelsliterature based discoveryLLMspharmacovigilance

Identifiers

PMID40979379
PMCPMC12443093

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.