Unfortunately, the original version of this article [1] contained an error. The correct paragraph can be found below: The calculation of number of patients was not correct. It was wrote the non-inferiority margin as 0.1 mm. But it was 0.19 mm in an original document. Non-inferiority margin in previous coronary intervention studies has been set between 0.1 ~ 0.2 mm. The 0.19 mm is not irrelevant...

BACKGROUND Subjects with breast cancer enrolled in trials may experience multiple events such as local recurrence, distant recurrence or death. These events are not independent; the occurrence of one may increase the risk of another, or prevent another from occurring. The most commonly used Cox proportional hazards (Cox-PH) model ignores the relationships between events, resulting in a potentia...

In drug development, non-inferiority tests are often employed to determine the difference between two independent binomial proportions. Many test statistics for non-inferiority are based on the frequentist framework. In this paper, we propose a method for the determination of sample sizes using the index ( ) , , 2 1 0 2 1 X X P ∆ − π > π = τ where 1 X and 2 X denote binomial random variables fo...

BACKGROUND Non-inferiority and equivalence trials require tailored methodology and therefore adequate conduct and reporting is an ambitious task. The aim of our review was to assess whether the criteria recommended by the CONSORT extension were followed. METHODS We searched the Medline database and the Cochrane Central Register for reports of randomised non-inferiority and equivalence trials ...

Placebo-controlled trials are the ideal for evaluating medical treatment efficacy. They allow for control of the placebo effect and are most efficient, requiring the smallest numbers of patients to detect a treatment effect. A placebo control is ethically justified if no standard treatment exists, if the standard treatment has not been proven efficacious, there are no risks associated with dela...

BACKGROUND There is no consensus on the preferred method for defining the non-inferiority margin in non-inferiority trials, and previous studies showed that the rationale for its choice is often not reported. This study investigated how the non-inferiority margin is defined in the published literature, and whether its reporting has changed over time. METHODS A systematic PubMed search was con...

BACKGROUND Direct oral anticoagulants that target a single coagulation factor have been developed as an alternative to standard therapies with heparin and/or vitamin K antagonists. The purpose of this study was to derive non-inferiority margins suitable for randomised clinical studies designed to evaluate these agents for the treatment of venous thromboembolism (VTE). METHODS We performed a s...

Social identity theory typically emphasizes how low status group members resist and challenge imputations of inferiority (Tajfel & Turner, 1979), whereas system justification theory emphasizes the tendency to accept and justify status hierarchies ( Jost & Banaji, 1994). On the theoretical assumption that responses to ingroup inferiority would vary according to individual differences in social d...

The importance of this condition lies in the fact that the cases are by no means uncommon, and that if the condition is recognized the child is saved much misery and the parents spared the expense and trouble of endeavouring to educate a child who through no fault of his own is incapable of achieving the results that are expected of him. The child will often develop an inferiority complex, as h...

OBJECTIVE To assess the non-inferiority of vonoprazan to lansoprazole for secondary prevention of non-steroidal anti-inflammatory drug (NSAID)-induced peptic ulcer (PU) and the safety of vonoprazan during extended use. DESIGN A phase 3, 24-week, multicenter, randomised, double-blind (DB), active-controlled study, followed by a phase 3, ≥28 week, multicenter, single-blind, parallel-group exten...