Research Councils UK (RCUK), the umbrella group for the councils that fund UK research, recently announced changes to their guidelines for animal experimentation. The announcement addressed shortcomings in the research. In particular, researchers were asked to “clearly describe how the planned experimental design is appropriate to give robust results”, and attention was called to “the sometimes inadequate standard of reporting of animal experiments in the scientific literature.”
The reality is that poor experimental design has blotted the copybook of the scientific community for some time. The new guidance from the UK’s funding heavy weights sends a strong signal that this must change.
Of particular concern is the number of animals used. RCUK pointed out that either too many or not enough animals are being used. The use of too few animals makes a study meaningless due to lack of statistical power, while the use of too many animals is a waste of animal lives.
“If the study is underpowered your results are not going to be reliable,” says Nathalie Percie du Sert, who works on experimental design at the National Centre for the Replacement, Refinement and Reduction (NC3Rs) of Animals in Research in London. “These animals are going to be wasted.
The reporting of animal experiments in the scientific literature is not seen as up to standard either. Last year, a group of researchers analysed published research papers on pre-clinical animal studies and found them lacking:
There is growing concern that poor experimental design and lack of transparent reporting contribute to the frequent failure of pre-clinical animal studies to translate into treatments for human disease. In 2010, the Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines were introduced to help improve reporting standards. They were published in PLOS Biology and endorsed by funding agencies and publishers and their journals, including PLOS, Nature research journals, and other top-tier journals. Yet our analysis of papers published in PLOS and Nature journals indicates that there has been very little improvement in reporting standards since then. This suggests that authors, referees, and editors generally are ignoring guidelines, and the editorial endorsement is yet to be effectively implemented.
The RSPCA’s response to the new RCUK guidance, as reported in the Guardian:
It is good that this problem has been put right but bad that it took so long to do so. Animals have suffered unnecessarily and patients have been let down because public money has been wasted on worthless research. We now need to see how robustly the agencies follow up these new guidelines and ensure scientists comply with them.
Study design and reporting are not the only problems though. Last year, the British Medical Journal published an article titled “Is animal research sufficiently evidence based to be a cornerstone of biomedical research?” The authors argued that the “benefits remain unproved and [animal research] may divert funds from research that is more relevant to doctors and their patients”. Further, they wrote:
The current situation is unethical. Poorly designed studies and lack of methodological rigour in preclinical research may result in expensive but ultimately fruitless clinical trials that needlessly expose humans to potentially harmful drugs or may result in other potentially beneficial therapies being withheld. Moreover, if poorly conducted studies produce unreliable findings, any suffering endured by animals loses its moral justification because their use cannot possibly contribute towards clinical benefit. Non-publication of animal studies is similarly unethical because the animals involved cannot contribute towards the accumulation of knowledge and because non-publication may result in further, unnecessary animal and human experiments.
There is much wrong with the way animal research is designed, analysed and reported. But let’s not forget that – most importantly – animals are not good models for humans and their diseases. Animal research is unnecessary, unreliable and unethical.
If you want to read more about animal research, the Humane Research Australia website lists (and links to) publications such as academic papers and government reports. Search for the keyword “bias” if you want to read about flawed research.