Evidence map›Paper›PMID 35579812›Full record

ArticleDrug safety2022

Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review.

Benjamin Kompa, Joe B Hakim, Anil Palepu, Kathryn Grace Kompa, Michael Smith, Paul A Bain, Stephen Woloszynek, Jeffery L Painter, Andrew Bate, Andrew L Beam

Erratum issuedAbstract readScoping Review
In one paragraph

Article in Drug safety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing 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

35 citing papers in PubMed.

  1. Article
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  5. Article
  6. How is AI developing in pharmacovigilance?Therapeutic advances in drug safety · 2026
    Article
  7. Article
  8. Article
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  11. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Benjamin KompaDepartment of Biomedical Informatics, Harvard Medical School, Boston, MA, USA.
Joe B HakimDepartment of Health Sciences and Technology, Harvard-MIT, Cambridge, MA, USA.
Anil PalepuDepartment of Health Sciences and Technology, Harvard-MIT, Cambridge, MA, USA.
Kathryn Grace KompaTufts University School of Medicine, Boston, MA, USA.
Michael SmithDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Paul A BainCountway Library of Medicine, Harvard Medical School, Boston, MA, USA.
Stephen WoloszynekBeth Israel Deaconess Medical Center, Boston, MA, USA.
Jeffery L PainterGlaxoSmithKline, Durham, NC, USA.
Andrew BateGlaxoSmithKline, Brentford, UK.
Andrew L BeamDepartment of Biomedical Informatics, Harvard Medical School, Boston, MA, USA. Andrew_Beam@hms.harvard.edu.

Funding

Training Program in Bioinformatics and Integrative GenomicsT32HG002295 · NHGRI · MASSACHUSETTS INSTITUTE OF TECHNOLOGY · PI Peter J Park · 2001 to 2026
$15.8M
Predicting Pulmonary and Cardiac Morbidity in Preterm Infants with Deep LearningK01HL141771 · NHLBI · HARVARD SCHOOL OF PUBLIC HEALTH · PI BEAM, ANDREW L. · 2019 to 2023
$832k
NHGRI NIH HHS T32 HG002295NHLBI NIH HHS K01 HL141771
6 · The paper itself

Abstract

introductionArtificial intelligence based on machine learning has made large advancements in many fields of science and medicine but its impact on pharmacovigilance is yet unclear.

objectiveThe present study conducted a scoping review of the use of artificial intelligence based on machine learning to understand how it is used for pharmacovigilance tasks, characterize differences with other fields, and identify opportunities to improve pharmacovigilance through the use of machine learning.

designThe PubMed, Embase, Web of Science, and IEEE Xplore databases were searched to identify articles pertaining to the use of machine learning in pharmacovigilance published from the year 2000 to September 2021. After manual screening of 7744 abstracts, a total of 393 papers met the inclusion criteria for further analysis. Extraction of key data on study design, data sources, sample size, and machine learning methodology was performed. Studies with the characteristics of good machine learning practice were defined and manual review focused on identifying studies that fulfilled these criteria and results that showed promise.

resultsThe majority of studies (53%) were focused on detecting safety signals using traditional statistical methods. Of the studies that used more recent machine learning methods, 61% used off-the-shelf techniques with minor modifications. Temporal analysis revealed that newer methods such as deep learning have shown increased use in recent years. We found only 42 studies (10%) that reflect current best practices and trends in machine learning. In the subset of 154 papers that focused on data intake and ingestion, 30 (19%) were found to incorporate the same best practices.

conclusionAdvances from artificial intelligence have yet to fully penetrate pharmacovigilance, although recent studies show signs that this may be changing.

Indexed as

Artificial IntelligencePharmacovigilanceHumansMachine Learning

Identifiers

PMID35579812
PMCPMC9883349

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.