Evidence map›Paper›PMID 35579809›Full record

ArticleDrug safety2022

Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance.

Raymond Kassekert, Neal Grabowski, Denny Lorenz, Claudia Schaffer, Dieter Kempf, Promit Roy, Oeystein Kjoersvik, Griselda Saldana, Sarah ElShal

Abstract read
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. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 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

22 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. How is AI developing in pharmacovigilance?Therapeutic advances in drug safety · 2026
    Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Review
  14. Article
  15. Editorial: AI/ML in pharmacovigilance and pharmacoepidemiology.Frontiers in drug safety and regulation · 2024
    Article
  16. Article
  17. Trustworthy AI for safe medicines.Nature reviews. Drug discovery · 2023
    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

9 authors.

Raymond KassekertGlaxoSmithKline, Global Safety, Upper Providence, PA, USA.
Neal GrabowskiAbbVie, Pharmacovigilance and Patient Safety Business Process Office, North Chicago, IL, USA. neal.grabowski@abbvie.com.ORCID http://orcid.org/0000-0002-7025-2508
Denny LorenzBayer AG, Medical Affairs and Pharmacovigilance, Pharmaceuticals, Berlin, Germany.
Claudia SchafferMerck Healthcare, Case and Vendor Management-Global Patient Safety, Darmstadt, Germany.
Dieter KempfGenentech, A Member of the Roche Group, South San Francisco, CA, USA.
Promit RoyNovartis, Chief Medical Office and Patient Safety, Novartis Global Drug Development, Dublin, Ireland.
Oeystein KjoersvikMSD, R&D IT, Prague, Czech Republic.
Griselda SaldanaAmgen, Pharmacovigilance Operations, Los Angeles, CA, USA.
Sarah ElShalUCB, IT Patient Safety, Brussels, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

TransCelerate reports on the results of 2019, 2020, and 2021 member company (MC) surveys on the use of intelligent automation in pharmacovigilance processes. MCs increased the number and extent of implementation of intelligent automation solutions throughout Individual Case Safety Report (ICSR) processing, especially with rule-based automations such as robotic process automation, lookups, and workflows, moving from planning to piloting to implementation over the 3 survey years. Companies remain highly interested in other technologies such as machine learning (ML) and artificial intelligence, which can deliver a human-like interpretation of data and decision making rather than just automating tasks. Intelligent automation solutions are usually used in combination with more than one technology being used simultaneously for the same ICSR process step. Challenges to implementing intelligent automation solutions include finding/having appropriate training data for ML models and the need for harmonized regulatory guidance.

Indexed as

Artificial IntelligencePharmacovigilanceAutomationHumansMachine LearningTechnology

Identifiers

PMID35579809
PMCPMC9114066

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.