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Recent policy initiatives by the US Food and Drug Administration and the National Institutes of Health have promoted new approach methodologies, including organoids, organ-on-chip platforms, and computational models, as alternatives to animal research. While new approach methodologies offer valuable tools for mechanistic investigation and screening applications, this review examines whether current new approach methodology technologies can adequately replace animal models in critical care research. Critical illness involves the whole organism, including dynamic organ\u2013organ interactions, immune\u2013microbiome crosstalk, and adaptive systemic feedback loops. By examining major domains in critical care research and targeted organ injuries, it becomes clear that while new approach methodologies excel at interrogating isolated subsystems, they cannot currently replicate integrated physiological responses. Animal models remain essential for questions requiring assessment of multiorgan dysfunction, therapeutic safety evaluation, and clinically relevant disease trajectories. Premature policy shifts away from animal research will impede advances in critical care medicine. This review proposes a \u201cmethodological pluralism\u201d approach that integrates new approach methodologies with appropriately designed animal studies through harmonized endpoints and reverse-translation frameworks. Recommendations include continued refinement of animal models to better represent the heterogeneity of human populations, adoption of quality standards for preclinical research, and strategic deployment of both new approach methodologies and animal models based on fit-for-purpose criteria. We believe this approach will satisfy ethical considerations, scientific rigor, and public health needs in critical care research.<\/jats:p>","DOI":"10.1093\/jleuko\/qiag108","type":"journal-article","created":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T12:05:18Z","timestamp":1785585918000},"source":"Crossref","is-referenced-by-count":0,"title":["New approach methodologies complement but cannot replace animal models in critical care medicine research"],"prefix":"10.1093","volume":"118","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0304-348X","authenticated-orcid":false,"given":"Marlene E","family":"Starr","sequence":"first","affiliation":[{"name":"Department of Surgery, University of Kentucky , 760 Press Ave, HKRB 238, Lexington, KY 40536 ,","place":["United States"]},{"name":"Department of Pharmacology and Nutritional Sciences, University of Kentucky , 760 Press Ave, HKRB 238, Lexington, KY 40536 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew D","family":"Taylor","sequence":"additional","affiliation":[{"name":"Division of Pediatric Critical Care, Department of Pediatrics, Cohen Children's Medical Center, Northwell Health and the Zucker School of Medicine at Hofstra\/Northwell , 269-01 76th Avenue, New Hyde Park, NY 11040 ,","place":["United States"]},{"name":"The Feinstein Institutes for Medical Research, Northwell Health , 350 Community Dr, Manhasset, NY 11030 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Longxiang","family":"Su","sequence":"additional","affiliation":[{"name":"Department of Critical Care Medicine, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences , Beijing 100730 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9801-3923","authenticated-orcid":false,"given":"Atsushi","family":"Murao","sequence":"additional","affiliation":[{"name":"The Feinstein Institutes for Medical Research, Northwell Health , 350 Community Dr, Manhasset, NY 11030 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4248-8545","authenticated-orcid":false,"given":"Steve J","family":"Schwulst","sequence":"additional","affiliation":[{"name":"Northwestern University, Feinberg School of Medicine , 259 E. 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