Statistical considerations in the design and analysis of non-inferiority trials with binary endpoints in the presence of non-adherence: a simulation study [version 2; peer review: 2 approved]

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...

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Bibliographic Details
Main Authors: Yin Mo, Cherry Lim, Mavuto Mukaka, Ben S. Cooper
Format: Article
Language:English
Published: Wellcome 2020-04-01
Series:Wellcome Open Research
Online Access:https://wellcomeopenresearch.org/articles/4-207/v2