Statistical considerations in the design and analysis of non-inferiority trials with binary endpoints in the presence of non-adherence: a simulation study (Supplementary material)

Mo Yin, Lim Cherry, & Cooper Ben
Protocol non-adherence is common and poses unique challenges in the interpretation of trial outcomes, especially in non-inferiority trials. We performed simulations of a non-inferiority trial with a time-fixed treatment and a binary endpoint in order to: i) explore the impact of various patterns of non-adherence and analysis methods on treatment effect estimates; ii) quantify the probability of claiming non-inferiority when the experimental treatment effect is actually inferior; and iii) evaluate alternative methods such as inverse...
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