title: Can animal data translate to innovations necessary for a new era of patient-centred and individualised healthcare? Bias in preclinical animal research.
abstract: BACKGROUND
  The public and healthcare workers have a high expectation of animal research which they perceive as necessary to predict the safety and efficacy of drugs before testing in clinical trials. However, the expectation is not always realised and there is evidence that the research often fails to stand up to scientific scrutiny and its 'predictive value' is either weak or absent.
  
  
  CONCLUSIONS
  Problems with the use of animals as models of humans arise from a variety of biases and systemic failures including: 1) bias and poor practice in research methodology and data analysis; 2) lack of transparency in scientific assessment and regulation of the research; 3) long-term denial of weaknesses in cross-species translation; 4) profit-driven motives overriding patient interests; 5) lack of accountability of expenditure on animal research; 6) reductionist-materialism in science which tends to dictate scientific inquiry and control the direction of funding in biomedical research. Bias in animal research needs to be addressed before medical research and healthcare decision-making can be more evidence-based. Research funding may be misdirected on studying 'disease mechanisms' in animals that cannot be replicated outside tightly controlled laboratory conditions, and without sufficient critical evaluation animal research may divert attention away from avenues of research that hold promise for human health. The potential for harm to patients and trial volunteers from reliance on biased animal data(1) requires measures to improve its conduct, regulation and analysis. This article draws attention to a few of the many forms of bias in animal research that have come to light in the last decade and offers a strategy incorporating ten recommendations stated at the end of each section on bias. The proposals need development through open debate and subsequent rigorous implementation so that reviewers may determine the value of animal research to human health. The 10Rs + are protected by a Creative Commons Attribution 3.0 Unported License and therefore may be 'shared, remixed or built on, even commercially, so long as attributed by giving appropriate credit with a link to the license, and indicate if changes were made.'
authors.affiliation: SABRE Research UK, PO BOX 18653, London, NW3 4UJ, UK. susan.green@sabre.org.uk.
authors.forename: Susan Bridgwood
authors.initials: SB
authors.lastname: Green
mesh_terms: D032761:Animal Experimentation / Q000941:ethics* / Q000592:standards; D000818:Animals; D015982:Bias; D035843:Biomedical Research / Q000941:ethics* / Q000592:standards; D003362:Cost-Benefit Analysis; D004195:Disease Models, Animal; D019317:Evidence-Based Medicine / Q000941:ethics; D006801:Humans; D018802:Patient-Centered Care / Q000941:ethics; D057285:Precision Medicine / Q000941:ethics; D012107:Research Design / Q000592:standards; D012941:Social Responsibility; D057170:Translational Research, Biomedical / Q000941:ethics