Biomedical Research Must Change — But a Shift Toward Human-specific Research Methods Is Only Part of What Is Needed

Abstract

The poor translation of animal research to human biology and clinical benefit is more widely acknowledged than ever before. Much of my work over the past 17 years has made a scientific case for the replacement of animal experimentation with human-specific methods for this reason, also arguing that such a paradigm shift has a human ethical basis, as well as being based on animal welfare. Over this time, the debate has grown from being largely argued by animal rights groups, to a movement that now involves stakeholders from every area of science, including academia, industry and regulators. Initiatives and roadmaps to expedite replacement specifically — not just the Three Rs generally — are ongoing, gathering momentum and finding success (for example). Furthermore, acknowledgements of poor translation/human relevance of animal-based approaches are stated frequently in papers in mainstream journals in a huge variety of specialist fields, as researchers increasingly look to new approach methodologies (NAMs) to find a better way forward. This is all very welcome, naturally. However, it may be a serious mistake to assume that this paradigm shift, when it happens, will be enough for biomedical research to reach its full potential. There are long-established and growing concerns among some academics around how biomedical research is conducted, over and above the methods and approaches it adopts. These concerns deserve much more attention than they currently receive. I recall many and regular conversations with my scientist colleagues during my time in academic research, lamenting certain aspects of how academia operated, how science was funded, the unfortunate weight of the ‘publish or perish’ mantra, and how research and researchers were assessed and assigned relative value. While this all took place almost 20 years ago, it is perhaps even more relevant today. No matter how good the very best, most human-relevant NAMs may be, if the drivers of research and the modus operandi of biomedical investigation are not optimal, then biomedical research itself will remain, at best, sub-par — and this has serious human ethical consequences. There must be a significant change in this respect, too, which would potentiate, enhance and maximise the capabilities of NAMs and human-specific research, ensuring significant increases in clinical translation and benefit. This limitation of research potential and translation to human benefit is a critical point. Notably, it is distinct from other calls for change in how research is conducted, calls for intellectual/academic freedom, complaints surrounding unnecessary ‘regulatory burden’ and so on. These concerns are not borne of frustration with the job and career, but of the purpose, goals, and main raison d’être of biomedical research: i.e. clinical impact and human benefit. The issues involved are many and varied, but are far from intractable, and have been summarised by many authors and researchers. They include: