RE: Yet again the market doesn't get it!19 Nov 2021 15:41
RP…and others who are baffled about “non- inferiority “ and don’t comprehend what the purpose and aims of such trials…
These are from references ncbi,fda,and others..
Non- inferiority trials may also be used when the new treatment may offer important advantages over currently available standard treatments, in terms of improved safety, convenience, better compliance, or cost. In addition, clinical trials are increasingly required to demonstrate benefits in clinical endpoints rather than surrogate endpoints, even though the incremental benefits from new treatments is diminishing, which is also an important factor in determining sample size. Such practical considerations are also driving a trend towards designing clinical trials that aim to demonstrate experimental treatments have similar effects to active controls of a proven efficacy rather than a superior effect.
The aim is to show that the new treatment is not inferior to the existing one – that is, it is either equally effective or better. If this can be established, the new treatment can be considered as a replacement for the existing treatment, especially if it has other advantages (e.g. cost, safety) which make it preferable.
non-inferiority is in fact more challenging than superiority?
Non-inferiority trials are generally large because of their need to exclude the possibility of a small degree of inferiority of a new agent relative to an active control. However if the new agent is actually superior to control by a small amount, then the power to show its non- inferiority is increased.
GL
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