Evidence map›Paper›PMID 30303528›Full record

ArticleClinical pharmacology and therapeutics2019

Innovation in Pharmacovigilance: Use of Artificial Intelligence in Adverse Event Case Processing.

Juergen Schmider, Krishan Kumar, Chantal LaForest, Brian Swankoski, Karen Naim, Patrick M Caubel

Abstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
–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

30 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Innovations in pharmacovigilance studies of medicines in older people.British journal of clinical pharmacology · 2025
    Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

6 authors.

Juergen SchmiderPfizer R&D, Lake Forest, Illinois, USA.
Krishan KumarPfizer Business Technology, Artificial Intelligence Center of Excellence, La Jolla, California, USA.
Chantal LaForestPfizer Global Product Development, Safety Solutions, Kirkland, Quebec, Ontario, Canada.
Brian SwankoskiPfizer Finance and Business Operations, Peapack, New Jersey, USA.
Karen NaimPfizer R&D, Collegeville, Pennsylvania, USA.
Patrick M CaubelPfizer R&D, New York, New York, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Automation of pharmaceutical safety case processing represents a significant opportunity to affect the strongest cost driver for a company's overall pharmacovigilance budget. A pilot was undertaken to test the feasibility of using artificial intelligence and robotic process automation to automate processing of adverse event reports. The pilot paradigm was used to simultaneously test proposed solutions of three commercial vendors. The result confirmed the feasibility of using artificial intelligence-based technology to support extraction from adverse event source documents and evaluation of case validity. In addition, the pilot demonstrated viability of the use of safety database data fields as a surrogate for otherwise time-consuming and costly direct annotation of source documents. Finally, the evaluation and scoring method used in the pilot was able to differentiate vendor capabilities and identify the best candidate to move into the discovery phase.

Indexed as

Adverse Drug Reaction Reporting SystemsArtificial IntelligenceDatabases, FactualDrug-Related Side Effects and Adverse ReactionsHumansPharmacovigilance

Identifiers

PMID30303528
PMCPMC6590385

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.