Knight
A. Reviewing existing knowledge prior to conducting
animal studies. Altern
Lab Anim 2008;
36(6): 707-712.
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ABSTRACT
Highly polarised viewpoints about animal experimentation
have often prevented agreement. However, important common
ground between advocates and opponents was demonstrated
within a discussion forum hosted at
www.research-methodology.org.uk in July–August 2008, by
the independent charity, SABRE Research UK. Agreement
existed that many animal studies have methodological
flaws — such as inappropriate sample sizes, lack of
randomised treatments, and unblinded outcome assessments
— that may introduce bias and limit statistical validity.
There was also agreement that systematic reviews of the
human utility of animal models yield the highest quality
of evidence, as their reliance on methodical and
impartial methods to select significant numbers of animal
studies for review, serves to minimise bias.
Unfortunately, disagreement remained that animal
experimental licence applications should reference
systematic reviews of existing studies, before approval.
The UK Medical Research Council requires that researchers
planning human clinical trials must reference such
reviews of related previous work. Existing knowledge is
thereby fully and appropriately utilised, and redundant
experimentation is avoided. However, objections were
raised that a similar requirement would interfere with
animal experimental licensing, because, to date, there
have been very few systematic reviews of animal studies.
In fact, the relative dearth of such reviews is a matter
of considerable concern, and may partially explain the
very poor human success rates of drugs that appear safe
and/or efficacious in animal trials. Nevertheless, the
disturbing number of human trials which have proceeded
concurrently with, or prior to, animal studies, or have
continued despite equivocal evidence of efficacy in
animals, clearly demonstrate that many researchers fail
to conduct adequate prior reviews of existing evidence.
Where neither sufficient primary studies, nor systematic
reviews of such studies, exist, for citation within a
licence application, researchers should be able to
provide evidence of this shortcoming, and, concurrently,
demonstrate that the available literature and evidence
have been adequately reviewed. This should also enable
them to clearly demonstrate the need and scientific
appropriateness of their proposed study, the validity of
its design, and — importantly — that the benefits are
reasonably likely to exceed the animal welfare,
bioethical and financial costs. Invasive animal studies
should never be permitted solely on the basis of less
probable, speculative or intangible human benefits, or
the mere satisfaction of scientific curiosity.