Non-inferiority trials criticised as unethical
Non-inferiority and equivalence trials for new drugs should be banned because they are unethical, say researchers.
They argue that non-inferiority trial designers can arbitrarily set allowable
limits of inferiority, meaning that test drugs could be less safe than
current therapy, without this being recognised. For example, the COMPASS
study determined the thrombolytic drug saruplase to be non-inferior to
streptokinase post-myocardial infarction, despite causing 35 more deaths
per 1,000 patients treated.
They conclude that non-inferiority trials answer no useful clinical question,
and it is unethical to recruit patients into a trial from which they
cannot benefit. Their criticism could extend to equivalence trials, which
aim to prove that a new product is not much worse (or much better) than
a comparator.
The article was published online in The
Lancet on 23 October 2007.
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