Evidence map›Paper›PMID 39156111›Full record

ArticleFrontiers in pharmacology2024

Artificial intelligence integration in the drug lifecycle and in regulatory science: policy implications, challenges and opportunities.

Wahiba Oualikene-Gonin, Marie-Christine Jaulent, Jean-Pierre Thierry, Sofia Oliveira-Martins, Laetitia Belgodère, Patrick Maison, Joël Ankri, Scientific Advisory Board of ANSM

Abstract read
In one paragraph

Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing 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

18 citing papers in PubMed.

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  6. Artificial Intelligence Across the Drug Development Lifecycle.Medical sciences (Basel, Switzerland) · 2026
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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.

Wahiba Oualikene-GoninAgence Nationale de Sécurité des Médicaments et des Produits de Santé (ANSM) Saint-Denis, Saint-Denis, France.
Marie-Christine JaulentINSERM, Laboratoire d'Informatique Médicale et d'Ingénierie des Connaissances en e-Santé, LIMICS, Sorbonne Université, Paris, France.
Jean-Pierre ThierryFrance Assoc Santé, Paris, France.
Sofia Oliveira-MartinsFaculty of Pharmacy of Lisbon University, Lisbon, Portugal.
Laetitia BelgodèreAgence Nationale de Sécurité des Médicaments et des Produits de Santé (ANSM) Saint-Denis, Saint-Denis, France.
Patrick MaisonAgence Nationale de Sécurité des Médicaments et des Produits de Santé (ANSM) Saint-Denis, Saint-Denis, France.
Joël AnkriUniversité de Versailles St Quentin-Paris Saclay, Inserm U1018, Guyancourt, France.
Scientific Advisory Board of ANSM

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Artificial intelligence tools promise transformative impacts in drug development. Regulatory agencies face challenges in integrating AI while ensuring reliability and safety in clinical trial approvals, drug marketing authorizations, and post-market surveillance. Incorporating these technologies into the existing regulatory framework and agency practices poses notable challenges, particularly in evaluating the data and models employed for these purposes. Rapid adaptation of regulations and internal processes is essential for agencies to keep pace with innovation, though achieving this requires collective stakeholder collaboration. This article thus delves into the need for adaptations of regulations throughout the drug development lifecycle, as well as the utilization of AI within internal processes of medicine agencies.

Indexed as

artificial intelligencedrug approval processdrug lifecyclehealth policypatient safetyregulatory science

Identifiers

PMID39156111
PMCPMC11327028

What OpenQuestion holds

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LicenceCC BY
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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.