Improving Design and Analysis of Research: Lessons from Clinical Research

Altman, Douglas G.

doi:10.1177/026119290403202s08

Cited by 2 publications

(1 citation statement)

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“…Firstly, there is growing concern about the overall standard of medical research, much of which is flawed, cannot be replicated and/or has limited use or no use — a situation referred to as a “scandal” by Altman back in 1994, 29 and highlighted by him again in 2004, in this journal. 30 Secondly, concerns about the quality of animal research that is conducted with a view to developing potential treatments for humans have been raised, for example, by Pound et al 24 and Pound and Nicol. 27 Fogel 31 also concluded that the poor quality of animal studies is one of the reasons why clinical trials fail.…”

Section: Harm–benefit Analysismentioning

confidence: 99%

It’s Time to Include Harm to Humans in Harm–Benefit Analysis — But How to Do It, That is the Question

Balls

2021

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The Three Rs ( reduction, refinement, replacement) concept put forward by Russell and Burch now appears to be widely accepted. However, their warnings concerning reliance on animals as models for humans, the insurmountable problem of species differences and the impact of human variation, have been downplayed or even ignored. Schemes for harm–benefit analysis have been introduced, but the focus has largely been on harm to the animals, rather than on the direct and indirect benefit to humans, which is much more difficult to evaluate. Greater recognition should be given to the direct or indirect harm to humans resulting from the current over-reliance of biomedical research and testing on data obtained from animal experiments. That will be hard to achieve in the current climate, given the vigorous defence of animal experimentation by those with vested interests, confusion over responsibilities for regulating animal experimentation, hierarchies of regulatory authorities which require or limit experiments on animals, and exaggerated claims about the current availability of new approach methodologies (NAMs) and relevant and reliable strategies for their use. Those who defend animal experimentation at almost any cost must bear part of the responsibility for the human harms which result. Meanwhile, much greater effort should be put into the development, validation and application of new approaches not involving animals.

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