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 …

Noninferiority trials are intended to show that the effect of a new treatment is not worse than
that of an active control by more than a specified margin. These trials have a number of …

When designing a noninferiority/equivalence trial, the sponsor intends to show efficacy by
demonstrating that a new treatment is as good as or not worse than a known effective …

Noninferiority trials comparing new treatment with an active standard control are becoming
increasingly common. This article discusses relevant issues regarding their need, design …

Non‐inferiority (NI) trials enable a direct comparison of the relative benefit‐to‐risk profiles of
an experimental intervention and a standard‐of‐care regimen. When the standard has …

The increased use of non-inferiority analysis has been accompanied by a proliferation of
research on the design and analysis of non-inferiority studies. Using examples from real …

New treatments that are potentially as effective as existing treatments are increasingly being
developed, some of which may be preferred because of lower cost, fewer side effects, easier …

To demonstrate in a clinical trial that a new or experimental therapy (et) is 'at least as good
as'a standard therapy (st), a statistical test or confidence interval procedure must rule out …

Without a placebo arm, any non‐inferiority inference involving assessment of the placebo
effect under the active control trial setting is difficult. The statistical risk for falsely concluding …

Active-control noninferiority trials are being performed with increasing frequency when
standard placebo-controlled trials are considered unethical. Three attributes are optimally …