Evidence map›Paper›PMID 40210953›Full record

ReviewNPJ digital medicine2025

Is regulatory science ready for artificial intelligence?

Thomas Hartung, Maurice Whelan, Weida Tong, Robert M Califf

Abstract readReview
In one paragraph

Review in NPJ digital medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing 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

22 citing papers in PubMed.

  1. Article
  2. Review
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  5. Article
  6. Review
  7. Review
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  9. Review
  10. Article
  11. Article
  12. Evidence-based AI: from trailblazer to trustblazer?Frontiers in artificial intelligence · 2026
    Article
  13. Review
  14. Article
  15. AI snake oil? A risk/benefit analysis for toxicology.Frontiers in artificial intelligence · 2026
    Article
  16. Review
  17. Review
  18. Review
  19. Article
  20. Review
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

4 authors.

Thomas HartungJohns Hopkins University, Bloomberg School of Public Health and Whiting School of Engineering, Baltimore, MD, USA.
Maurice WhelanEuropean Commission, Joint Research Center (JRC), Ispra, Italy.
Weida TongNational Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, USA. weida.tong@fda.hhs.gov.
Robert M CaliffOffice of Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Trust is key in AI for regulatory science, but its definition is debated. If AI models use different features yet perform similarly, which should be trusted? If scientific theories must be testable, how critical is explainability? At the Global Summit on Regulatory Science (GSRS24), regulators agreed that successful AI adoption requires ongoing dialogue, adaptability, and AI-trained personnel to harness its potential for regulatory responsibilities in the evolving 21st-century landscape.

Identifiers

PMID40210953
PMCPMC11985935

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.