Dear all,
as you may know, in many clinical trials it is often not ethically acceptable to include a control group with no treatment. One option is to use a wait-list, but in many cases we end up comparing two interventions. It is in such scenario that I have been recommended to prepare a noninferiority trial, instead of the more typical superiority trial.
Does any of you have in mind any resource or material to prepare this type of study? I am especially interested in sample size estimation and statistical analyses to be proposed in the protocol.
Thank you,
Hi JC,
In a non-inferiority trial, you have to consider at least two treatment conditions (as you would do with a superiority- or equivalent trial). You can check: Article Understanding noninferiority trials
Article Superiority, equivalence, and non-inferiority trials
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/non-inferiority-clinical-trials
[https://www.fda.gov/media/78504/download]
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