There are several alleged reasons for using equivalence or non-inferiority trials rather than superiority designs. The true reason is that proving non-inferiority of new products is less risky than aiming to establish their superiority. Failure to prove superiority can tarnish the product's commercial image, but it may provide more information for physicians and patients. This is why non-inferiority trials clearly aim to over look differences that might stop the product from getting onto the market, rather than highlighting them, so as to define true place for the new treatment in therapy. A demonstration of non-inferiority leaves the product in a kind of limbo: its place in therapy is not established, but its place on the market is assured. This paper tries to prove that the scientific community should ban non-inferiority and equivalence trials simply because they are unethical, no matter which measures are taken to prevent their methodological pitfalls and inappropriate interpretation of results. Randomisation should not even be allowed, since it is unethical to leave it to chance whether patients receive a treatment that, at best, is the same as what they would have received anyway, but might also reduce most of the previous therapeutic advantages. Furthermore, the uncertainty surrounding alleged non-inferiority is hard to accept: however small the allowed increase in relative risk, it unavoidably implies an unacceptable absolute excess of adverse events in the patient population.
|Translated title of the contribution||Non inferiority trials are unethical|
|Number of pages||7|
|Journal||Ricerca e Pratica|
|Publication status||Published - Mar 2008|
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