Method of control selection and margin choice in non-inferiority trials

Abstract

Abstract: Non-inferiority trial is a type of design which can show that the clinical effect of the experimented medicine is no worse than the active control medicine. In the recent years, owing to the ethical limit of placebo-controlled trail and existence of many active medicines, non-inferiority trial designs have been widely used. Unfortunately, some non-inferiority trial designs have many flaws because of the lack of the golden rules, including disaccord to the applied condition, incorrect selection of the active control, irrationality of the margin conformation and etc. In this paper, control selection and margin choice are discussed and summarized mostly, combining with many overseas researches, in order to provide some suggestions to the design and practice of non-inferiority trial in our country.

Key words: non-inferiority trial, comparator, margin

CLC Number:

R969

MA Yu-quan, ZHOU Jun, ZHOU Ai-ping, YIN Ping. Method of control selection and margin choice in non-inferiority trials[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(9): 961-965.

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