“Translating Animal Research into Clinical Benefit”, 2007-01-27 (; similar):
Poor methodological standards in animal studies mean that positive results rarely translate to the clinical domain… in a systematic review reported in this week’s BMJ Perel and colleagues find that therapeutic efficacy in animals often does not translate to the clinical domain.2 The authors conducted meta-analyses of all available animal data for six interventions that showed definitive proof of benefit or harm in humans. For three of the interventions—corticosteroids for brain injury, antifibrinolytics in haemorrhage, and tirilazad for acute ischaemic stroke—they found major discordance between the results of the animal experiments and human trials. Equally concerning, they found consistent methodological flaws throughout the animal data, irrespective of the intervention or disease studied. For example, only eight of the 113 animal studies on thrombolysis for stroke reported a sample size calculation, a fundamental step in helping to ensure an appropriately powered precise estimate of effect. In addition, the use of randomization, concealed allocation, and blinded outcome assessment—standards that are considered the norm when planning and reporting modern human clinical trials—were inconsistent in the animal studies.
…What can be done to remedy this situation? Firstly, uniform reporting requirements are needed urgently and would improve the quality of animal research; as in the clinical research world, this would require cooperation between investigators, editors, and funders of basic scientific research. A more immediate solution is to promote rigorous systematic reviews of experimental treatments before clinical trials begin. Many clinical trials would probably not have gone ahead if all the data had been subjected to meta-analysis. Such reviews would also provide robust estimates of effect size and variance for adequately powering randomized trials. A third solution, which Perel and colleagues call for, is a system for registering animal experiments, analogous to that for clinical trials. This would help to reduce publication bias and provide a more informed view before proceeding to clinical trials. Until such improvements occur, it seems prudent to be critical and cautious about the applicability of animal data to the clinical domain.