Ace the ACRP Clinical Research Pro Exam 2025 – Dash into Data with Confidence!

A non-inferiority study is specifically designed to evaluate whether a new treatment is at least as effective as a standard treatment, rather than proving it superior. This type of study sets a threshold (or margin) to demonstrate that the new treatment does not perform significantly worse than the established treatment, allowing researchers to conclude that the new treatment is a viable alternative.

In non-inferiority studies, the key focus is on establishing that the proposed treatment is "not worse" than the standard treatment by more than a predetermined amount. This is particularly useful in clinical scenarios where a new treatment could offer other benefits, such as fewer side effects or easier administration.

In contrast, a superiority study aims to prove that one treatment is better than another, while an equivalence study focuses on demonstrating that two treatments are similar in effectiveness, often within a predefined margin of equivalence. A factorial study is designed to explore multiple interventions simultaneously and their interaction effects but does not specifically aim to compare with a standard treatment in the same context.