The Need for a Paradigm Shift Print this Page If our finite public funds are to be used responsibly, they must fund reliable research and test methods that lead to the effective treatment of diseases and protection of human health and the environment. There has long been evidence that experiments on animals are impeding the development of treatments and cures for human ailments. The shift in scientific consensus away from the use of animals in experimentation and testing can be observed in several arenas, including publications documenting the limited predictive value of experiments on animals, an increased awareness of animal cognition and sentience, and the fast-eroding public support for animal use. While some measures had been initiated around the world to plan the phase-out of animal experimentation and testing, 1234 it wasn’t until 2025 that U.S. federal agencies began a dedicated shift away from the status quo.5678 The changes taking place are significant, but they’re only a start. Accomplishing the phase-out of animal experimentation and testing requires well-defined planning, coordinated action, measurability, and transparency. Research Modernization NOW provides a framework by which policy makers, funders, companies, and researchers can plan the necessary interventions to transition away from animal use entirely. A move away from experiments and tests on animals would allow for substantial growth in the science and technology sectors, leading to faster returns on investment in drug R&D,9 as seen after the cosmetics testing ban in the EU. Redirecting research funding priorities toward human-relevant methods—which recapitulate human physiology and biology without using animals or their tissue—will deliver treatments to patients more safely and likely in less time.101112 In support of using an evidence-based approach to accelerating the delivery of useful drugs to the patients who need them, a 2017 article called for the elimination of animal use in experiments in which there is clear evidence that animals are not useful or predictive of human disease: The literature is replete with examples of contradictions and discordance between animal and human effects, including many cases in which promising animal results have failed to translate to clinically significant efficacy in humans. This is particularly true in some therapeutic areas such as neurodegenerative, psychiatric, and central nervous system diseases, as well as sepsis and inflammatory diseases. These complexities inherent in translational research present an important opportunity for exploring novel approaches that successfully and efficiently yield outcomes as proximal as possible to eventual human benefit. Supported by several illustrative examples encountered in our drug repurposing program, we propose herein an approach for assessing when it is appropriate to conduct the “last experiment first,” that is, progressing directly to human investigations when animal work would likely fail to provide data appropriate for translation into human applications of interest. This represents a significant—and we suggest, avoidable—barrier to drug introduction.13 References Pound P, Bracken MB. Is animal research sufficiently evidence based to be a cornerstone of biomedical research? BMJ. 2014;348:g3387. doi:10.1136/bmj.g3387 ↩︎Strauss M. Americans are divided over the use of animals in scientific research. Pew Research Center. Accessed February 15, 2023. https://www.pewresearch.org/fact-tank/2018/08/16/americans-are-divided-over-the-use-of-animals-in-scientific-research/ ↩︎Newport F. Trends in U.S. adults’ acceptance of moral and values behaviors. Gallup.com. September 4, 2025. Accessed February 7, 2026. https://news.gallup.com/opinion/polling-matters/694550/trends-adults-acceptance-moral-values-behaviors.aspx ↩︎Müller N. Phase-out planning for animal experimentation: a definition, an argument, and seven action points. ALTEX. 2024;41(2):260-272. doi:10.14573/altex.2312041 ↩︎U.S. Food and Drug Administration. FDA announces plan to phase out animal testing requirement for monoclonal antibodies and other drugs. FDA.gov. April 10, 2025. Accessed February 6, 2026. https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs ↩︎National Institutes of Health. NIH to prioritize human-based research technologies. NIH.gov. April 29, 2025. Accessed February 6, 2026. https://www.nih.gov/news-events/news-releases/nih-prioritize-human-based-research-technologies ↩︎Kime P. Cats and dogs will no longer be used in Navy research, Secretary says. Military.com. June 2, 2025. Accessed February 6, 2026. https://www.military.com/daily-news/2025/06/03/cats-and-dogs-will-no-longer-be-used-navy-research-secretary-says.html ↩︎Grimm D. Exclusive: CDC to end all monkey research. Science. September 21, 2025. Accessed February 6, 2026. https://www.science.org/content/article/exclusive-cdc-end-all-monkey-research ↩︎Meigs L, Smirnova L, Rovida C, Leist M, Hartung T. Animal testing and its alternatives—the most important omics is economics. ALTEX. 2018;35(3):275-305. doi:10.14573/altex.1807041 ↩︎Hartung T. The (misleading) role of animal models in drug development. Front Drug Discov. 2024;4. doi:10.3389/fddsv.2024.1355044 ↩︎Kramer LA, Greek R. Human stakeholders and the use of animals in drug development. Bus Soc Rev. 2018;123(1):3-58. doi:10.1111/basr.12134 ↩︎Piesing M. How tech could spell the end of animals in drugs testing. The Guardian. https://www.theguardian.com/science/2014/aug/23/tech-end-animals-drugs-testing. August 23, 2014. Accessed October 22, 2024 ↩︎Pulley JM, Jerome RN, Zaleski NM, et al. When enough is enough: decision criteria for moving a known drug into clinical testing for a new indication in the absence of preclinical efficacy data. Assay Drug Dev Technol. 2017;15(8):354-361. doi:10.1089/adt.2017.821 ↩︎