Evidence map›Paper›PMID 42112047›Full record

ReviewF1000Research2025

Methods2AOP: A Collaboration to Strengthen the Integration of Test Methods into the Adverse Outcome Pathway Framework.

Agnes L Karmaus, William Bisson, Albert Braeuning, Xiaoqing Chang, Laure-Alix Clerbaux, Julija Filipovska, Jennifer Fostel, Ksenia Groh, Ginnie Hench, Eftychia Lekka and 13 more

Abstract readReview
In one paragraph

Review in F1000Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

23 authors.

Agnes L KarmausInotiv, Research Triangle Park, USA.
William BissonInotiv, Research Triangle Park, USA.
Albert BraeuningBundesinstitut fur Risikobewertung, Berlin, Berlin, Germany.
Xiaoqing ChangInotiv, Research Triangle Park, USA.
Laure-Alix ClerbauxUniversite catholique de Louvain Institut de Recherche Experimentale et Clinique, Louvain, Belgium.
Julija FilipovskaIndependent Researcher, Ohrid, North Macedonia.
Jennifer FostelNational Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, USA.
Ksenia GrohEawag Swiss Federal Institute of Aquatic Science and Technology, Zurich, Switzerland.ORCID https://orcid.org/0000-0002-3778-4721
Ginnie HenchOpenBioDataModeling, Research Triangle Park, USA.
Eftychia LekkaBiovista, Athens, Greece.
Scott G LynnUS Environmental Protection Agency, Washington, USA.
Kelly A MaguranyVerto Solutions LLC, Washington DC, USA.
Kristan MarkeyUS Environmental Protection Agency, Washington, USA.ORCID https://orcid.org/0000-0003-3911-2969
Anna Maria MasciThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Holly MortensenUS Environmental Protection Agency, Washington, USA.ORCID https://orcid.org/0000-0002-3180-5229
Jason M O'BrienEnvironment and Climate Change Canada National Wildlife Research Centre, Ottawa, Ontario, Canada.ORCID https://orcid.org/0000-0002-2546-8940
Emily ReinkeInotiv, Research Triangle Park, USA.
Nyssa TuckerThe University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Vassilis VirvilisBiovista, Athens, Greece.
Barbara VivianiUniversita degli Studi di Milano-Bicocca, Milan, Lombardy, Italy.
Sara VlietUS Environmental Protection Agency, Washington, USA.
Clemens WittwehrEuropean Commission Joint Research Centre, Ispra, Italy.ORCID https://orcid.org/0000-0003-2760-7702
Helena T HogbergNational Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Adverse Outcome Pathway (AOP) framework is a pivotal tool for organizing mechanistic knowledge and linking it to adverse outcomes of regulatory significance. However, the integration of test method information, particularly New Approach Methods (NAMs), within the central repository for AOP knowledge, (the AOP-Wiki), has been suboptimal, limiting the framework's utility for regulatory decision-making. The Methods2AOP collaboration, comprised of various international stakeholders, was established to address this gap and enhance the role of test methods within the AOP framework. This paper reviews their work emphasizing the importance of linking detailed test method information and conceptually proposes how it may be included in the AOP knowledgebase in alignment with existing assay documentation standards and governance frameworks. The Methods2AOP collaboration proposes using ontologies to standardize and structure information, thereby facilitating interoperability, enabling reusability, and establishing clear connections between test methods and Key Events (KEs). A conceptual model is presented to demonstrate qualitative similarities between concepts in key event components and structured methods information. The implementation of Methods2AOP recommendations would increase the clarity and transparency of method descriptions, which could support regulatory acceptance and a wider adoption of NAMs. The broad community of stakeholders impacted by this work stands to benefit from the Methods2AOP recommendations through enhanced regulatory decisions, increased visibility and scientific impact, new market opportunities, and the accelerated adoption of NAMs in regulatory affairs. In summary, the Methods2AOP collaboration presents a comprehensive effort to formally standardize the integration of test methods into the AOP framework, thereby fostering a more robust, and transparent system that aligns with the goals of the scientific and regulatory communities.

Indexed as

Adverse Outcome PathwaysKnowledge BasesCooperative BehaviorHumansAdverse Outcome Pathways (AOPs)New Approach Methods (NAMs)ontologiesregulatory framework

Identifiers

PMID42112047
PMCPMC13151919

What Socratic 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 Socratic graph.