Evidence map›Paper›PMID 42569723›Full record

ArticleNAM journal2026

Modelling the regulatory toxicology system to promote the effective use of new approach methodologies: a system thinking approach.

Angela Bearth, Birgit Kopainsky, Lowenna B Jones, Gunn E Vist, Trine Husøy, Camilla Svendsen, Paul Whaley, Sebastian Hoffmann, Heather M R Ames, Denise Bloch and 12 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in NAM journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

22 authors.

Angela BearthNorwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway.
Birgit KopainskyNorwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway.
Lowenna B JonesNorwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway.
Gunn E VistNorwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway.
Trine HusøyNorwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway.
Camilla SvendsenNorwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway.
Paul WhaleyNorwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway.
Sebastian HoffmannEvidence-Based Toxicology Collaboration (EBTC), Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA.
Heather M R AmesNorwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway.
Denise BlochDepartment of Pesticides Safety, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.
Aleksandra ČavoškiBirmingham Law School, University of Birmingham, UK.
Holly G DaviesWashington State Department of Health, Tumwater, WA, USA.
Arianna GiustiCosmetics Europe Avenue Herrmann-Debroux 40, 1160 Auderghem, Belgium.
Thomas HartungCenter for Alternatives to Animal Testing (CAAT), Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA.
Seok KwonDepartment of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Olivia J OsborneChemical Risk Assessment Team, Science, Evidence and Research Division, Food Standards Agency, Westminster, London, UK.
Christophe RousselleANSES/DAEI-French Agency for Food, Environmental and Occupational Health & Safety, 14 rue Pierre et Marie Curie - 94701 Maisons-Alfort Cedex, France.
Jennifer B SassNatural Resources Defense Council, Washington DC, USA.
Ulla SimanainenChemicals Agency (ECHA), Helsinki 00121, Finland Directorate of Regulatory Cooperation, Biocides and Water, European, Finland.
Kristina A ThayerOffice of Environmental Health Hazard Assessment (OEHHA), Sacramento, CA, USA.
Daniele WikoffToxStrategies, Asheville, NC, USA.
Gro H MathisenNorwegian Scientific Committee for Food and Environment, Norwegian Institute of Public Health, Oslo, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The term "New Approach Methodologies" (NAMs) comprises a plethora of approaches with the potential for testing the safety, efficacy, and biological effects of chemicals, pharmaceuticals, and other substances without relying exclusively on traditional animal testing methodologies. While it is debateable whether "new" is the appropriate terminology - some NAMs have been around for several decades, while others have been developed recently - many scholars have observed that the effective uptake of NAMs in regulatory toxicology remains a challenge. The interdisciplinary CHANGE project applies a systems thinking approach to this challenge by modelling the behaviour of the regulatory toxicology system shaped by system-level factors and their interconnections. This article reports findings from two three-day workshops held in Oslo in summer 2024 (Workshop 1 "Explore") and 2025 (Workshop 2 "Reflect") with experienced practitioners from regulatory agencies, industry, civil society organisations and academia. Through structured collaborative activities, including small- and large-group discussions, modelling exercises and reflection activities, considerable qualitative data was gathered. Most sessions were recorded, transcribed, and analysed using a multi-step thematic analysis explicitly guided by systems thinking principles, enabling the identification of systemic structures and feedback mechanisms and their visualization in the form of a systems model. Insights from Workshop 1 "Explore" were revisited and stress-tested in Workshop 2 "Reflect", deepening the robustness of the resulting systems model. This systems model shows structural, economic, social, cultural and technical factors that are interlinked through reinforcing and balancing feedback loops that promote or inhibit the effective use of NAMs. The systems model shows potential leverage points for system change, for instance enhancing the stability and reliability of the supply chain or ensuring that actors in the regulatory toxicology system have both educational and institutional support to effectively change established practices.

Indexed as

Chemical risk assessmentNew approach methodologiesNext generation risk assessmentSystems thinking

Identifiers

PMID42569723
PMCPMC13450631

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.