BACKGROUND

Animals are used in medical research to observe disease mechanisms and in pre-clinical trials mainly to test pharmaceutical drug treatments. They are used as ‘models’ with the purpose of learning about the progression of disease in humans and to predict the safety and efficacy of drugs and surgical interventions (treatments) intended to benefit human health. Animal research forms a large part of biomedical research and, while it is mainly used for drug development and testing, many other fields of medicine also use it. In medical research it attracts proportionately more funding than clinical research (research focusing on humans). The process of evaluating animal studies for their relevance to human medicine is therefore critical and it is our concern that animal research is insufficiently regulated to achieve a high enough standard of conduct and evaluation. This lack of scientific rigour in the design and evaluation of animal research consequently affects the quality of clinical research and can result in harm to patients and research volunteers and waste resources. Systematic reviews are recognized by the research community as one of the best ways of determining the value of research. They also give assurance that the research results have a standard of scientific defensibility.

WHAT IS NEEDED TO IMPROVE MEDICAL RESEARCH:

• The same standards of evaluation to be applied to animal research that are applied to clinical research -

WHY? - because it will serve to improve safety and efficacy of medical research.

• Large-scale programmes of systematic reviews of existing animal studies

WHY? - because the research community consider systematic reviews to be the best research tool available to evaluate research

• Prospective registration of animal studies and a standardised method of reporting.

WHY? because it will improve the accountability of animal research and reduce biased reporting. (Biased reporting is where negative results are not reported leaving positive results looking better than they might in fact be)

• Education about the value of systematic reviews of animal studies and evidence-based research methods

WHY? because patients and the public are empowered if they understand the importance of how the research that affects them is evaluated
 
• Better quality and adequate information about animal studies should be made available to Phase l trial volunteers where the clinical trials are based on animal data

WHY? - because it is unethical to withhold relevant information from volunteers participating in research

More reasons why systematic reviews of animal studies should be funded:

• They will allow researchers to determine the generalizability (relevance) of animal research to human medicine

• They will promote accountability of animal research; minimise bias; reduce potential for exaggerated or unsupported claims; apply more reliably the 3Rs principles of replacement; reduction and refinement; and optimize an evidence-based approach to animal research.

• It is unethical [in medical research] to conduct more studies while existing studies have not been evaluated using systematic reviews

• Funding is wasted where animal research is poorly conducted and not evaluated through systematic reviews

• The scientific evaluation of animal research is fundamental to the cost-benefit assessment of any research

• Failure to prepare and refer to systematic reviews of existing evidence from animal studies can result in harm to human health.

What are systematic reviews and research synthesis?

A systematic review refers to the entire process of collecting, reviewing and presenting all available evidence. The process is a methodological tool that researchers use in a science called research synthesis. Research synthesis is a relatively new science that aims to assemble evidence about the benefits and harms of a variety of medical and social interventions using explicit, scientifically defensible methods (systematic reviews). The aim of this process, in contrast to traditional approaches to assessing research evidence, is to minimise bias, and to seek and appraise research studies in a systematic and standard way. The process aims to make the best estimate of the "truth" about what works and what is harmful, and highlights gaps in knowledge.'

Home Office Immigration and Nationality Directorate, 2002. Refugee integration: Can research synthesis inform policy? Feasibility study report Yongmi Schibel, Mina Fazel, Reive Robb and Paul Garner. London: Home Office

The scandalous failure of scientists to cumulate scientifically

New research should not be designed or implemented without first assessing systematically what is known from existing research. The failure to conduct that assessment represents a lack of scientific self-discipline which results in an inexcusable waste of public resources. In applied fields like health care, failure to prepare scientifically defensible reviews of relevant animal and human data results not only in wasted resources but also in unnecessary suffering and premature death. All new research - whether basic or applied - should be designed in the light of scientifically defensible syntheses of existing research evidence, and reported setting the new research in the light of the totality of the available evidence, thus making clearer to readers what contribution – if any - new studies have made to knowledge.

From a presentation for the Scottish Wellcome Trust Clinical Research Facility
Edinburgh, 30 June 2005

Evidence-based research

‘Evidence-based medicine does not seem to have penetrated basic and preclinical science, while basic and preclinical research is often performed in a clinical and methodological vacuum.’

John P. A. Ioannidis, Evolution and Translation of Research Findings: From Bench to Where?, PLOS Clinical Trials, November, 2006