ReviewBiomimetics (Basel, Switzerland)2025
Integrating New Approach Methodologies (NAMs) into Preclinical Regulatory Evaluation of Oncology Drugs.
Review in Biomimetics (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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.
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.
Who cites it
13 citing papers in PubMed.
- Organoid Intelligent Morphomics: Decoding the organoid morphome through artificial intelligence from phenotypic quantification to mechanistic insight.Bioactive materials · 2027Review
- Using Organoids to Unlock the Potential of Human Torpor for Spaceflight.Current stem cell reports · 2026Article
- Lipid nanoparticle delivery of antisense gapmers attenuates pathology in a mouse model of facioscapulohumeral muscular dystrophy.Molecular therapy : the journal of the American Society of Gene Therapy · 2026Article
- Accelerating the clinical translation of bioengineered anticancer therapeutics.Journal of the National Cancer Center · 2026Article
- Label-Free Myelin Fingerprinting: An Adult Human Post-Mortem Brain Slice Platform via Coherent Anti-Stokes Raman Spectroscopy.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Review
- Review
- A virtual cohort framework with applications to adoptive cell therapy in bladder cancer.bioRxiv : the preprint server for biology · 2026Article
- 3D biofabricated in vitro models as new approach methodologies for animal alternatives.npj biomedical innovations · 2026Review
- Review
- Need for NAMs: A systematic evidence synthesis revealing over half a century of drug development failure.NAM journal · 2026Article
- Article
- Patient-derived organoids in gastric cancer: bridging the tumor microenvironment to functional precision oncology.Frontiers in bioengineering and biotechnology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Traditional animal-based preclinical models, including xenografts and genetically engineered mice, have been used for assessing pharmacodynamics, toxicity, efficacy, and safety for decades. Despite their limited ability to mimic human tumor heterogeneity, immune interactions, and microenvironmental complexity, over 90% of oncology candidates that succeed in animal studies fail in clinical trials. The New Approach Methodologies (NAMs), which include patient-derived organoids, organ-on-chip platforms, and AI-driven computational models, provide human-relevant solutions that can improve predictive validity, mechanistic insight, and ethics. Through these technologies, it will be possible to replicate tumor biology specific to patients, to support co-clinical trial designs, and to facilitate biomarker discovery while reducing animal testing. Several recent regulatory reforms, including the Food and Drug Administration (FDA) Modernization Act 2.0 and the European Medicines Agency's NAM qualification framework, have established clear pathways for the integration of validated NAMs into preclinical drug evaluation. Critically evaluating the scientific rationale, comparative performance, and regulatory context of key NAM platforms in oncology, this review highlights opportunities for synergistic integration, technical refinement, and global harmonization in order to accelerate the development of clinically effective cancer therapeutics based on preclinical findings.
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What Socratic holds
Registered trials
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.