AI Summary
The article discusses the use of non-inferiority design in trials for comparing new drugs with existing standards in the context of multiple sclerosis. Non-inferiority trials aim to show that a new drug is at least as effective as the existing one, with potential benefits such as fewer side effects or easier administration. This design targets a different research question than superiority trials, but it is more complex and typically requires larger sample sizes for proper interpretation.
When effective treatments exist, trials compare new drugs with those standards using either a superiority or non-inferiority design. Superiority trials aim to prove that a new drug is better than an existing one. Non-inferiority trials aim to show that a new drug is at least as effective, with potential benefits such as fewer side effects or easier administration. A non-inferiority design is neither better nor worse than a superiority design, but simply targets a different research question. However, it is crucial to recognise that the design and interpretation of non-inferiority trials is more complex than that of superiority trials, and generally requires larger sample sizes.