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The hybrid preclinical ecosystem: a strategic roadmap for oncology R&D
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DOI：10.1093/jnci/djag173.png)
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Abstract
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Regulatory shifts, economic pressures, and pandemic-related logistical disruptions have challenged the long-standing primacy of animal models in biomedical research. In oncology, the traditional "animal-first" paradigm is increasingly difficult to defend as advances in human-derived systems—including tumor organoids, microphysiological systems, and computational models—now enable the study of specific aspects of tumor biology in experimentally controlled and human-relevant contexts. Consequently, the conceptual architecture of preclinical research is being reorganized; rather than suggesting a replacement of animal models, these changes point to a gradual reconfiguration of how different model systems are positioned within the translational pipeline. This shift necessitates a fundamental reassessment of how experimental design translates into clinical relevance. A strategic roadmap for this hybrid ecosystem illustrates how the integration of human-specific data and refined animal validation can de-risk clinical translation in oncology.
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