Most clinical trials are designed to show that a new intervention is superior to an existing intervention (or to no intervention, if none is currently available). These designs are called superiority trials. However, sometimes a new intervention is not expected to be clinically superior to an existing product, but has other advantages, (i.e. being cheaper, easier to administer, or has a better safety profile).
To conclude that the clinical efficacy of new intervention is “at least as good” as the current intervention, one should use a non-inferiority trial design. Establishing non-inferiority means that the clinical efficacy of the experimental intervention is, at worst, only marginally inferior to that of the existing intervention. This margin of clinical unimportance is pre-defined prior to study commencement.
To understand the concepts of non-inferiority trials and how they differ from superiority trials.
• Define non-inferiority
• Explain why non-inferiority trials are conducted
• Give concrete examples when a non-inferiority trial should be used
• State the principles for defining eligibility and treatment selection in non-inferiority trials
• Expound on the need for rigorous design and conduct of non-inferiority trials
• Clarify the need for both intention to treat and per protocol analyses for non-inferiority trials
• Descibe how to use the results of a non-inferiority trial, in particular the confidence interval for the primary endpoint, in deciding whether non-inferiority has been shown
Evangelista, MT & Huber, NE. (2017) Non-inferiority trials: Why, what and how?. Journal of the Philippine Dermatological Society, 26(1), 8-11.
non-inferiority trial, epidemiology, trial
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A randomized, double-blind, comparative study on the safety and efficacy of virgin coconut (Cocos nucifera l.) oil against 1% hydrocortisone lotion as an anti-inflammatory and antipruritic preparation for mosquito reactions
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Primary Cutaneous Anaplastic Large Cell Lymphoma (PC-ALCL) is a rare Non-Hodgkin lymphoma (NHL) representing approximately 9% of all cutaneous lymphomas.3 It usually manifests as a slow-growing, solitary tumor which has a tendency to regress spontaneously. However, metastasis is reported in 5-10% of cases.