Noninferiority trials are used to assess whether the effect of a new drug is not worse than an
active comparator by more than a noninferiority margin. If the difference between the new …

Now updated with new data and examples throughout, Clinical Epidemiology: Principles,
Methods, and Applications for Clinical Research, Second Edition is a comprehensive …

A noninferiority trial is designed to demonstrate that an experimental therapy is not worse
than an active control. Although noninferiority trials are superficially similar to conventional …

Background/aims Non-inferiority trials with time-to-event outcomes are becoming
increasingly common. Designing non-inferiority trials is challenging, in particular, they …

Objective NI margins have to be chosen appropriately to control the risk of degradation of
treatment effects in non-inferiority (NI) trials. We aimed to study whether the current choice of …

Three-arm non-inferiority (NI) trial including the experimental treatment, an active reference
treatment, and a placebo where the outcome of interest is binary are considered. While the …

Background: Intranasal (IN) midazolam allows for rapid, painless treatment of pediatric
seizures in the prehospital setting and may be a preferred administration route if determined …

Objectives The efficacy and safety of intravenous thrombolysis uncertain in patients with non-
disabling mild ischemic stroke. Our aim was to investigate whether best medical …

Non-inferiority (NI) trials can be used in a situation when a new drug is expected to have a
similar efficacy to its comparator but can offer other advantages over the existing drug, such …

BackgroundTraditional decision rules have limitations when a new technology is less
effective and less costly than a comparator. We propose a new probabilistic decision …